Surgical Sutures Portfolio

Surgical sutures portfolio

The depth you want. The strength you need.

Advanced surgical suture solutions developed with surgeons, tailored for your specialty — always focused on your patients’ needs

Decades of expertise in your surgical specialty

Drawn from in-depth expertise, our sutures are designed to help you with the real-world challenges of wound closure in your surgical specialty.

A proven track record in meaningful innovation

As a world leader in sutures, we have a proven record in delivering surgical advances that foster better outcomes.

Strength and confidence for you and your patients

Our intent is to design sutures to hold strong and perform for you and your patients.

Barbed sutures

Not all barbed sutures are alike.

V-Loc™ wound closure device

Engineered with a dual angle cut design for multiple applications, designed for surgeons.

The circumferential pattern of the V-Loc™ wound closure device delivers uniform barbs in a 360° helix that locks into tissue, for traction and anchoring.^†,1,2

Even tension distribution may help minimize tissue trauma promoting faster closure and better cosmesis.^‡,§,3–7

It's the barbs that make the difference.

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Indications, Safety, and WarningsIndicationsV-Loc™ 180 absorbable wound closure devices are indicated for use during surgical interventions where use of an absorbable suture is appropriate. The intended purpose of the device is soft tissue approximation.Contraindictions

The use of the V-Loc™ 180 absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.

The V-Loc™ 180 absorbable wound closure device is not for use where prolonged (beyond 3 weeks) approximation of tissues under stress is required or for fixation of prosthetic devices (e.g., heart valves or synthetic grafts).

The V-Loc™ 180 absorbable wound closure device should not be used for interrupted suture patterns.

The V-Loc™ 180 absorbable wound closure device is not intended to be used by tying surgical knots.

The V-Loc™ 180 absorbable wound closure device should not be used for ligating vessels or luminal structures.

Warnings and precautions

The safety and effectiveness of the V-Loc™ 180 absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery.

Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.

V-Loc™ 180 absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.

Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.

Small bowel obstructions due to barbed suture ends hooking onto adjacent small bowel and/or mesentery have been reported; these are potentially associated with volvulus, bowel infarction, and significant morbidity.

Suture failure may result in bleeding, wound dehiscence, or infection.

This device is provided sterile for single-use only. Sterile unless packaging has been opened or damaged. Visually inspect package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Intended users are healthcare professionals who have been trained in surgical procedures and techniques involving absorbable sutures. Before employing the V-Loc™ 180 devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.

Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption and sterile abscess may occur.

V-Loc™ 180 absorbable wound closure device should only be used with continuous suture patterns. Do not use V-Loc™ 180 absorbable wound closure device in a continuous locking pattern.

Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.

In handling this or any other device, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

Since foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds. The V-Loc™ 180 absorbable wound closure devices did not enhance infection in animal studies. Dispose of used devices and packaging materials in accordance with standard hospital procedures and universal precautions for biohazardous waste.

During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.

Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.

IndicationsV-Loc™ 90 absorbable wound closure devices are indicated for use during surgical interventions where use of an absorbable suture is appropriate. The intended purpose of the device is soft tissue approximation. Contraindications

The use of the V-Loc™ 90 absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.

The V-Loc™ 90 absorbable wound closure device is not for use where prolonged (beyond 2 weeks) approximation of tissues under stress is required or for fixation of prosthetic devices (e.g., heart valves or synthetic grafts).

The V-Loc™ 90 absorbable wound closure device should not be used for interrupted suture patterns.

The V-Loc™ 90 absorbable wound closure device is not intended to be used by tying surgical knots.

The V-Loc™ 90 absorbable wound closure device should not be used for ligating vessels or luminal structures.

Warnings and precautions

The safety and effectiveness of the V-Loc™ 90 absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery.

Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.

The V-Loc™ 90 absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.

Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.

Suture failure may result in bleeding, wound dehiscence, or infection.

This device is provided sterile for single use only. Sterile unless packaging has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Intended users are healthcare professionals who have been trained in surgical procedures and techniques involving absorbable sutures. Before employing the V-Loc™ 90 devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.

Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption and sterile abscess may occur.

V-Loc™ 90 absorbable wound closure device should only be used with continuous suture patterns. Do not use V-Loc™ 90 absorbable wound closure device in a continuous locking pattern.

Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.

Since foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds. The V-Loc™ 90 absorbable wound closure devices did not enhance infection in animal studies. Dispose of used devices and packaging materials in accordance with standard hospital procedures and universal precautions for biohazardous waste.

IndicationsV-Loc™ PBT non-absorbable wound closure devices are indicated for use during surgical interventions. The intended purpose of the device is soft tissue approximation.Contraindications

The use of the V-Loc™ PBT non-absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.

The V-Loc™ PBT non-absorbable wound closure device should not be used for interrupted suture patterns.

The V-Loc™ PBT non-absorbable wound closure device is not intended to be used by tying surgical knots.

V-Loc™ PBT non-absorbable wound closure device is not intended to be used in direct contact with the heart, the central circulatory system or the central nervous system.

Warnings and precautions

The safety and effectiveness of the V-Loc™ PBT non-absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery.

Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.

The V-Loc™ PBT non-absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.

Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.

Suture failure may result in bleeding, wound dehiscence, or infection.

Before employing the V-Loc™ PBT devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.

The V-Loc™ PBT non-absorbable wound closure device should only be used with continuous running suture patterns. Do not use V-L oc™ PBT non-absorbable wound closure device in a continuous locking pattern.

Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.

The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.

During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one-half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the non-absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.

The device contains nickel that may cause allergic reaction.

Absorbable sutures

With a track record of delivering reliable⁸ sutures for your surgical field, you can be confident in your wound closures with Medtronic.

Trexon™ monofilament synthetic absorbable suture

Pliable, yet strong.^◊,8

By combining greater pliability^◊,8 with 3-week-long tensile strength and absorption in 90 to 110 days,^†,8,9 Trexon™ monofilament synthetic absorbable sutures embody the next evolution in Medtronic wound closure offerings.

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Indications, Safety, and WarningsIndicationsTrexon™ monofilament synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological surgery.Contraindications

This suture, being absorbable, should not be used where extended approximation of tissue is required.

Warnings

This device is provided sterile for single-use only. Sterile unless packaging has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Before employing Trexon™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

The device needle contains nickel that may cause allergic reaction.

Precautions

In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon.

The use of additional throws may be particularly appropriate when knotting monofilaments.

Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.

Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption, and sterile abscess may occur.

Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures.

Dispose of used sutures in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.

Image of our suture products in their packaging

Biosyn™ monofilament absorbable suture

Biosyn™ monofilament absorbable sutures are prepared from a synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.

Indications, Safety, and WarningsIndications
Biosyn™ sutures are indicated for use in general soft tissue approximation and/or ligation. The intended purpose of the suture is soft tissue approximation and/or ligation.ActionsBiosyn™ sutures elicit a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of Biosyn™ sutures occurs by means of hydrolysis where the suture is broken down to glycolic acid, dioxanoic acid, propane diol, and carbon dioxide which are subsequently absorbed and metabolized by the body.Absorption begins as a loss of tensile strength without appreciable loss of mass. Studies in indicate tensile strength averages for Biosyn™ sutures are approximately 75% of United States Pharmacopeia (USP) and European Pharmacopoeia (EP) minimum knot strength at two weeks and approximately 40% of USP and EP at three weeks post-implant. Absorption of Biosyn™ sutures is essentially complete between 90 and 110 days.ContraindicationsThis suture, being absorbable, should not be used where extended approximation of tissue is required. Biosyn™ sutures should not be used on cardiovascular or neural tissues.Warnings

This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures.

Before employing Biosyn™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Suture failure may result in bleeding, wound dehiscence, or infection.

This device contains nickel that may cause allergic reaction.

Maxon™ monofilament absorbable suture

Maxon™ monofilament absorbable sutures are indicated for use in general soft tissue approximation and ligation, including in pediatric cardiovascular tissue.

Indications, Safety, and WarningsIndications
Maxon™ and Maxon™ CV sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.Actions
Maxon™ and Maxon™ CV synthetic absorbable sutures elicit a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of Maxon™ and Maxon™ CV synthetic absorbable sutures occurs by means of hydrolysis where the suture is broken down and subsequently absorbed and metabolized by the body.Studies indicate that tensile strength for Maxon™ and Maxon™ CV sutures is approximately 80% of the original suture strength at one week post implant. Approximately 75% of the original suture strength remains at two weeks, 65% at three weeks, 50% at four weeks, and 25% at six weeks post-implant. Absorption of Maxon™ and Maxon™ CV synthetic absorbable sutures is minimal until about the sixtieth day after implantation. Absorption is substantially complete within six months.Contraindictions

The use of this suture is contraindicated in patients with known sensitivities or allergies to its components.

This suture, being absorbable, should not be used where extended approximation of tissue is required or fixation of permanent cardiovascular prostheses or synthetic grafts.

Warnings

This device is provided sterile, for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other, suture with salt solutions, as calculus formation may result.

Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Maxon™ and Maxon™ CV synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Precautions

Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

In handling this or any other suture material care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted be surgical circumstances and the experience of the surgeon.

The use of additional throws may be particularly appropriate when knotting monofilaments.

Care should be exercised when knotting sutures used in continuous mass or layered closure of the abdomen, i.e., non-slip locking knots should be used at both ends of the continuous closure.

The commonly used looped-to-stand knot during termination of a running suture is a configuration, which may lead to slippage. Extreme care must be used to ensure that multiple square knots are well secured.

Sutures in vaginal mucosa or skin, that remain in place for extended periods may be associated with localized irritation and should be removed as indicated.

Since any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds.

Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements.

Polysorb™ braided absorbable suture

Polysorb™ sutures are used in surgical interventions, including ophthalmic surgery for the purpose of soft tissue approximation and ligation.

Indications, Safety, and WarningsIndicationsPolysorb™ sutures are indicated for use during surgical interventions, including ophthalmic surgery, for the purpose of soft tissue approximation and ligation, where use of an absorbable suture is appropriate. The intended purpose of the suture is soft tissue approximation or ligation.Warnings

This device is provided sterile for single-use only. Do not reuse, reprocess or resterilize this device. Reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the sterile barrier system and packaging before use. Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures. Store at room temperature.

Before employing Polysorb™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.

As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate in patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in closure of the abdomen, chest, joints or other sites subject to expansion or requiring additional support.

In surgery of the urinary or biliary tracts, care should be taken to avoid prolonged contact of this, or any other, suture with salt solutions, as calculus formation may result.

Suture failure may result in bleeding, wound dehiscence, infection or vision loss (when used in ophthalmic procedures).

Verify proper needle selection for application when performing ophthalmic procedures. Use of the incorrect needle may cause damage resulting in vision loss.

This device contains nickel that may cause allergic reaction.

Velosorb™ fast braided absorbable suture

Velosorb™ braided fast absorbable sutures are composed of an absorbable synthetic polyester comprised of glycolide and lactide.

Indications, Safety, and WarningsIndicationsVelosorb™ fast absorbable sutures are indicated for use in soft tissue approximation of the skin, mucosa, and conjunctiva, where only 7 to 10 days of wound support is required, but not for use in ligation, cardiovascular, or neurological tissue.Warnings

Do not resterilize. Sterile unless packaging has been opened or damaged. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

In surgery of the urinary or biliary tracts, care should be taken to avoid prolonged contact of this, or any other, suture with salt solutions, as calculus formation may result.

Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Velosorb™ fast absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

The use of this suture may be inappropriate in patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in closure of the abdomen, chest, joints, or other sites subject to expansion or requiring additional support.

Caprosyn™ monofilament absorbable suture

Caprosyn™ sutures are designed to hold tight during the critical first 10 days of healing, and to be fully absorbed within approximately 56 days. This can lead to minimized splitting or extrusions.

Indications, Safety, and WarningsIndicationsCaprosyn™ synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation.ContraindictionsThis suture, being absorbable, should not be used where extended approximation of tissue is required.Warnings

Reuse, reprocessing, and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury. Do not reuse, reprocess, or resterilize this device.

As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.

Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Caprosyn™ synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical procedure must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

The subject device should not be used in patients who are allergic to device materials.

The device needle contains nickel that may cause allergic reaction.

NOTE: Not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Gut absorbable sutures

Explore our gut suture options.

Chromic gut absorbable suture

Chromic gut absorbable sterile surgical sutures are composed of purified connective tissue derived from the serosal layer of beef intestines.

Indications, Safety, and WarningsIndicationsPlain, chromic, and mild chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological surgery and microsurgery.ActionsWhen plain, chromic, and mild chromic gut absorbable sutures are placed in tissue, a moderate tissue inflammation occurs characteristic of foreign body response to a substance. This is followed by a gradual loss of tensile strength and suture mass, as the enzymatic process dissolves the surgical gut until it is completely absorbed. Many variable factors may affect the rate of absorption. Some of the major factors which may affect tensile strength loss and absorption rates are:

Type of suture — Plain gut is expected to absorb more rapidly than chromic gut.

Infection — Surgical gut is absorbed faster in infected tissue than in noninfected tissue.

Tissue sites — Surgical gut will absorb more rapidly in tissue where increased levels of enzymes are present, as in secretions exhibited in the stomach, cervix, and vagina.

Contraindictions

The use of these sutures is contraindicated in patients with known sensitivities or allergies to bovine collagen or chromium, as gut is a collagen based material and chromic gut is treated with chromic salt solutions.

This suture, being absorbable, should not be used where extended approximation of tissue is required.

Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Do not resterilize. Sterile unless packaging has been opened or damaged.

Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Users should be familiar with surgical procedures and techniques involving gut sutures before using plain, chromic, and mild chromic gut absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Certain patients may be hypersensitive to bovine collagen or chromium and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation and the potential for allergic reactions including delayed anaphylactic reaction.

Precautions

Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.

The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.

Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon to reduce the occurrence of surface fraying and weakening of the strand.

Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

Mild chromic gut absorbable suture

Mild chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery.

Indications, Safety, and WarningsContraindicationsThe use of these sutures is contraindicated in patients with known sensitivities or allergies to bovine collagen or chromium, as gut is a collagen based material and chromic gut is treated with chromic salt solutions.This suture, being absorbable, should not be used where extended approximation of tissue is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Do not resterilize. Sterile unless packaging has been opened or damaged.

Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Plain gut absorbable suture

Plain gut sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery.

Indications, Safety, and WarningsIndicationsPlain, chromic, and mild chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological surgery and microsurgery.ContraindicationsThe use of these sutures is contraindicated in patients with known sensitivities or allergies to bovine collagen or chromium, as gut is a collagen based material and chromic gut is treated with chromic salt solutions.This suture, being absorbable, should not be used where extended approximation of tissue is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Do not resterilize. Sterile unless packaging has been opened or damaged. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Resources

Gut Suture Cross Reference Guide: (open in new window)

Cross reference guide to provide information on the correct Medtronic SKU to use as it relates to the Ethicon discontinued SKU

PDF 350 KB

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Nonabsorbable sutures

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Surgipro™ monofilament suture

The Surgipro™ sutures with PTFE have:

Greater tensile strength^{†,◊,10⁠-14}
More resistant to the possibility of breakage^{†,◊,10⁠-14}
Resistant to fraying^{†,◊,10⁠-14}
Improved handling characteristics^{†,◊,10⁠-14}

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Indications, Safety, and WarningsContraindictionsNone known.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Reuse, reprocessing, and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment, or life-threatening injury. Do not reuse, reprocess, or resterilize this device. Sterile unless packaging has been opened or damaged. Discard open, unused sutures. Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Surgipro™ polypropylene sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

Precautions

See a close up of the Surgipro™ II suture in action.

Dermalon™ monofilament nylon suture

Dermalon™ monofilament nylon sutures are inert, nonabsorbable, sterile surgical sutures used in general soft tissue approximation and/or ligation.

Indications, Safety, and WarningsIndicationsMonosof ™ and Dermalon™ monofilament and Surgilon™ braided nylon sutures, are indicated for use in general soft tissue approximation and/or ligation.ContraindictionsDue to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon sutures should not be used where permanent retention of tensile strength is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury. Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Monosof ™, Dermalon™, or Surgilon™ sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

The subject device should not be used in patients who are allergic to device materials.

These sutures are not intended to be used in the cardiovascular system.

Monosof™ monofilament nylon suture

Monosof™ monofilament nylon sutures are inert, nonabsorbable, sterile surgical sutures used in general soft tissue approximation and/or ligation.

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

The subject device should not be used in patients who are allergic to device materials.

These sutures are not intended to be used in the cardiovascular system.

Novafil™ monofilament polybutester suture

Novafil™ nonabsorbable monofilament surgical sutures are composed of polybutester fiber for use in general soft tissue approximation and/or ligation.

Indications, Safety, and WarningsIndicationsNovafil™ polybutester sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmology.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

This device is provided sterile and is intended for use in a single procedure only. Discard after use. Do not ResterIize. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Discard open, unused sutures.

Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Novafil™ sutures for wound closure as the risk of wound dehiscence may vary with the site of application and the suture material used.

Due to elasticity of the suture, extreme care and/or change in technique must be utilized when tensioning continuous or parachute sutures during vascular procedures or anastomotic bleeding may result.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the non-absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.

The device contains nickel that may cause allergic reaction.

Sofsilk™ silk suture

Sofsilk™ silk sutures are nonabsorbable, sterile, nonmutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin.

Indications, Safety, and WarningsIndicationsSofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.Contraindictions The use of this suture is contraindicated in patients with known sensitivities or allergies to silk.Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, Sofsilk™ sutures should not be used where permanent retention of tensile strength is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the nonabsorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.

The device contains nickel that may cause allergic reaction.

Steel monofilament stainless steel

The steel monofilatment is composed of 316L stainless steel conforming to ASTM standard F138 stainless steel bar and wire for surgical implants.

Indications, Safety, and WarningsIndications Steel sutures are indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair and sternal closure.
Contraindictions The use of these sutures is contraindicated in patients with known sensitivities or allergies to steel and/or its principal metallic components, chromium and nickel. Additionally, the presence of steel may interfere with certain radiodiagnostics and its use is contraindicated where radiotransparency of suture material is required.Warnings

Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing steel sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life threatening injury. Do not reuse, reprocess or resterilize this device.

Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements.

Surgidac™ polyester suture

Surgidac™ polyester sutures are braided, nonabsorbable, sterile surgical sutures for use in general soft tissue approximation and/or ligation.

Indications, Safety, and WarningsActionsSurgidac™ polyester sutures elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. Surgidac™ polyester sutures are not absorbed, nor is any significant change in tensile strength retention known to occur in vivo.ContraindictionsNone known.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment, or life-threatening injury. Do not reuse, reprocess, or resterilize this device. Sterile unless packaging has been opened or damaged. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Users should be familiar with surgical procedures and techniques involving sutures before employing Surgidac™ polyester nonabsorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

Surgilon™ braided nylon suture

Surgilon™ braided nylon sutures are nonabsorbable surgical sutures indicated for use in general soft tissue approximation and/or ligation.

Indications, Safety, and WarningsIndications

Monosof™ and Dermalon™ monofilament and Surgilon™ braided nylon sutures are indicated for use in general soft tissue approximation and/or ligation.

Contraindictions Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon sutures should not be used where permanent retention of tensile strength is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

The subject device should not be used in patients who are allergic to device materials.

These sutures are not intended to be used in the cardiovascular system.

Ti-cron™ coated braided polyester suture

Ti-Cron™ polyester sutures are indicated for use in general soft tissue approximation and/or ligation.

Indications, Safety, and WarningsIndicationsTi-Cron™ polyester sutures are indicated for use in general soft tissue approximation and/or ligation.ActionsTi-Cron™ polyester sutures elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. Ti-Cron™ polyester sutures are not absorbed, nor is any significant change in tensile strength retention known to occur in vivo.ContraindictionsNone known.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Reuse, reprocessing, and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment, or life-threatening injury. Do not reuse, reprocess, or resterilize this device. Sterile unless packaging has been opened or damaged. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.

Users should be familiar with surgical procedures and techniques involving sutures before employing Ti-Cron™ polyester nonabsorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

Topical skin adhesives

LiquiBand®* Exceed™ XS topical skin adhesive

LiquiBand®* Exceed™ XS topical skin adhesive is an ideal solution for small incisions and laparoscopic port closures.

Indications, Safety, and WarningsIndications LiquiBand®* Exceed™ XS is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand®* Exceed™ XS may be used in conjunction with, but not in place of, deep dermal stitches.Contradictions

Do not use on any wounds with evidence of microbial, bacterial, or fungal infections or gangrene.

Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids.

Do not use on patients that have a hypersensitivity to cyanoacrylates or formaldehyde.

Do not apply internally, inject intravascularly, or ingest.

Do not use on decubitus ulcers, animal or human bite wounds, or stab wounds.

Adverse reactionsClinical use of cyanoacrylate-based topical skin adhesives has suggested that the following adverse events may occur: wound dehiscence; infection; acute inflammation including erythema, edema and drainage; bonding to unintended tissues such as the eye; thermal discomfort during polymerization; allergic reaction; foreign body reaction; and chronic non-healing of a wound.

LiquiBand®* Exceed™ topical skin adhesive

LiquiBand®* Exceed™ is a 2-octyl-cyanoacrylate topical skin adhesive designed for medium to long surgical incisions.

Indications, Safety, and WarningsIndications LiquiBand®* Exceed™ topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand®* Exceed™ topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.Contraindictions

Do not use on any wounds with evidence of microbial, bacterial, or fungal infections or gangrene.

Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids.

Do not use on patients that have a hypersensitivity to cyanoacrylates or formaldehyde.

Do not apply internally, inject intravascularly, or ingest.

Do not use on decubitus ulcers, animal or human bite wounds, or stab wounds.

Warnings LiquiBand®* Exceed™ topical skin adhesive is a fast-setting adhesive capable of adhering to most body tissues and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, surface, and/or equipment that is not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided.Polymerization of LiquiBand®* Exceed™ topical skin adhesive may be accelerated by water or fluids containing alcohol. LiquiBand®* Exceed™ topical skin adhesive should not be applied to wet wounds. LiquiBand®* Exceed™ topical skin adhesive should not be applied to the eye. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.When closing facial wounds near the eye using LiquiBand®* Exceed™ topical skin adhesive, adjust the patient’s position so that any flow of the adhesive is away from the eye. The eye should be closed and protected with gauze. Strategic placement of petroleum jelly near the eye can be effective at preventing inadvertent flow of the adhesive into the eye. Use of adhesives near the eye has inadvertently caused some patients’ eyelids to be sealed shut. In some of these cases, general anaesthesia and surgical intervention has been needed to open the eyelid.

LiquiBand®* Exceed™ topical skin adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where LiquiBand®* Exceed™ topical skin adhesive is intended to adhere.

LiquiBand®* Exceed™ topical skin adhesive is not absorbable and therefore should not be used below the skin as it may cause a foreign body reaction.

LiquiBand®* Exceed™ topical skin adhesive should not be used in areas with high or increased skin tension, such as knuckles, elbows, or knees unless the joint will be immobilized during the skin healing period or the skin tension has been decreased by application of another wound closure device (e.g., sutures or skin staples) prior to application of LiquiBand®* Exceed™ topical skin adhesive.

LiquiBand®* Exceed™ topical skin adhesive treated wounds should be monitored for signs of infection. Wounds with signs of infection such as erythema, edema, warmth, pain, and/or drainage should be evaluated and treated according to standard practice for infection.

LiquiBand®* Exceed™ topical skin adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.

LiquiBand®* Exceed™ topical skin adhesive should be used only on wounds that have easily apposed edges which have been thoroughly cleaned, debrided and otherwise closed in accordance with standard surgical practice. Local anaesthetic should be used when necessary to ensure adequate cleansing and debridement.

LiquiBand®* Exceed™ topical skin adhesive should always be applied sparingly, bridging the wound and the aligned wound edges. Avoid pressure on the applicator to prevent wound edge separation, which could cause the topical skin adhesive to be interposed between the wound edges. Application and/or migration (leak) of the topical skin adhesive below the surface of the skin between the wound edges may impair the healing process by forming a barrier.

LiquiBand®* Exceed™ topical skin adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying LiquiBand®* Exceed™ sparingly onto a dry wound, heat is released slowly and the sensation of heat or pain experienced by the patient is minimized. However, if LiquiBand®* Exceed™ topical skin adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort.

LiquiBand®* Exceed™ topical skin adhesive is packaged for a single patient use. Discard remaining opened material after each wound closure procedure.

Do not re-sterilize LiquiBand®* Exceed™ topical skin adhesive or include it in a procedure pack/tray that is to be sterilized prior to use. Exposure of LiquiBand®* Exceed™ topical skin adhesive after its final manufacture, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam), is known to increase viscosity and may render the product unusable.Precautions This product is meant for external dermal application only. Hold the applicator away from yourself and the patient and break the ampoule close to its center one time only. Do not crush the contents of the applicator tube repeatedly as further manipulation of the applicator may cause glass shard penetration of the plastic tube.

The safety and effectiveness of LiquiBand®* Exceed™ topical skin adhesive has not been evaluated for use on wounds of patients with uncontrolled diabetes mellitus, diseases or conditions that are known to interfere with the wound healing process, or a personal or family history of keloid formation or hypertrophic scarring.

Safety and effectiveness have not been evaluated on wounds that have been treated with LiquiBand®* Exceed™ topical skin adhesive and then exposed for prolonged periods of time to direct sunlight and tanning lamps.

LiquiBand®* Exceed™ topical skin adhesive permeability by topical medications or other fluids is not known and has not been studied.

Liquid, ointment, or cream medications should not be applied to the wound after closure with LiquiBand®* Exceed™ topical skin adhesive, as these substances may weaken the polymerized film which may allow for wound dehiscence.

If unintended bonding of intact skin with LiquiBand®* Exceed™ topical skin adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine™* or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

LiquiBand®* Exceed™ topical skin adhesive is a viscous liquid prior to polymerization. To prevent inadvertent flow of LiquiBand®* Exceed™ topical skin adhesive to unintended areas the wound should be placed in a horizontal position, with LiquiBand®* Exceed™ topical skin adhesive applied from above.

Adverse reactions Clinical use of cyanoacrylate-based topical skin adhesives has suggested that the following adverse events may occur: wound dehiscence; infection; acute inflammation including erythema, edema and drainage; bonding to unintended tissues such as the eye; thermal discomfort during polymerization; allergic reaction; foreign body reaction and chronic non-healing of a wound.

LiquiBand® Exceed™ XL Topical Skin Adhesive

LiquiBand®* XL skin closure system

The LiquiBand®* XL system offers a unique octyl-based cyanoacrylate formulation that provides many advantages for large and high-tension wounds.

Indications, Safety, and WarningsIndications LiquiBand®* XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.LiquiBand®* XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.Contraindictions

Do not use on any wounds with evidence of infection or gangrene, or on wounds of decubitus etiology.

Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips), or on skin that may be regularly exposed to body fluids or with dense natural hair (e.g., scalp).

Do not use on patients with a known hypersensitivity to cyanoacrylate, formaldehyde, benzyltributyl ammonium bromide, or pressure-sensitive adhesive.

Warnings

LiquiBand®* XL incorporates a fast-setting liquid adhesive capable of adhering to most body tissue and to many other materials, such as surgical gloves and stainless steel. Inadvertent contact with any body tissue, and any surfaces or equipment that are not disposable or that cannot be readily cleaned with a solvent such as acetone, should be avoided.

Polymerization of the liquid adhesive component may be accelerated by water or fluids containing alcohol. LiquiBand®* XL should not be applied to wet wounds.

LiquiBand®* XL should not be applied to the eye. If contact of the liquid adhesive with the eye occurs, flush the eye copiously with saline or water. If residual liquid adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.

When closing facial wounds near the eye with LiquiBand®* XL, position the patient so that any run-off of the liquid adhesive is away from the eye. The eye should be closed and protected with gauze. Prophylactic placement of petroleum jelly around the eye to act as a mechanical barrier or dam can be effective in preventing inadvertent flow of liquid adhesive into the eye. LiquiBand®* XL will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where LiquiBand®* XL is intended to adhere. Use of liquid adhesive near the eye has inadvertently caused some patients’ eyelids to be sealed shut. In some of these cases, general anesthesia and surgical removal has been required to open the eyelid.

LiquiBand®* XL should not be used below the skin because the polymerized material is not absorbed by tissue and can elicit a foreign body reaction.

LiquiBand®* XL should not be used in high skin tension areas or across areas of increased skin tension, such as joints, unless the area will be immobilized during the skin healing period or unless skin tension has been removed by application of another wound closure device (e.g., sutures or skin staples) prior to application of LiquiBand®* XL.

LiquiBand®* XL treated wounds should be monitored for signs of infection. Wounds with signs of infection, such as erythema, edema, warmth, pain, and pus, should be evaluated and treated according to standard practice for infection.

LiquiBand®* XL should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.

LiquiBand®* XL should only be used after wounds have been cleaned, debrided, and are otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to ensure adequate cleansing and debridement.

Excessive pressure of the applicator tip against the wound edges or surrounding skin can force the wound edges apart and allow liquid adhesive into the wound. Liquid adhesive within the wound could delay wound healing or result in adverse cosmetic outcome, or both. Therefore, the LiquiBand®* XL liquid adhesive component should be applied with a very light brushing motion of the applicator tip over the mesh and surrounding skin area.

LiquiBand®* XL liquid adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying LiquiBand®* XL liquid adhesive in a single layer onto a dry wound, heat is released slowly and the sensation of heat or pain experienced by the patient is minimized. However, if LiquiBand®* XL liquid adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort.

LiquiBand®* XL is packaged for single patient use. Discard remaining opened material after each wound closure procedure.

Do not resterilize LiquiBand®* XL. Reuse of this device (or portions of this device) may create a risk of product degradation and/or cross-contamination, which may lead to product failure or infection or transmission of bloodborne pathogens to patients and users.

Do not place LiquiBand®* XL in a procedure pack/tray that is to be sterilized prior to use without prior written authorization from manufacturer. Exposure of LiquiBand®* XL after its final manufacture to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam), is known to increase its viscosity and may render the product unusable.

Only for use on adults up to a combined total of 88 cm of mesh and liquid adhesive on a single patient and children (14 kg) up to a combined total of 22 cm of mesh and liquid adhesive on a single patient.

Precautions

Do not apply liquid or ointment medications, or other substances, to the wound after closure with LiquiBand®* XL, as these substances can weaken the polymerized film and allow for wound dehiscence. LiquiBand®* XL permeability by topical medications has not been studied. Prior to application, cleanse the application site thoroughly to remove any remaining blood, fluids, or topical medications/anesthetics.

LiquiBand®* XL permeability by fluids is not known and has not been studied.

LiquiBand®* XL liquid adhesive, as a liquid, is slightly more viscous than water. To prevent inadvertent flow of liquid adhesive to unintended areas, the wound should be held in a horizontal position, with LiquiBand®* XL liquid adhesive applied from above. Any excess liquid adhesive can be quickly wiped off with sterile gauze. If unintended bonding of intact skin with the adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine®, or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

If unintended bonding of intact skin with the adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine® or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

Safety and effectiveness of LiquiBand®* XL on wounds of patients with peripheral vascular disease, insulin-dependent diabetes mellitus, blood clotting disorders, personal or family history of keloid formation or hypertrophy, or burst stellate lacerations, have not been studied.

Safety and effectiveness of LiquiBand®* XL on the following wounds have not been studied: animal or human bites, puncture, or stab wounds.

Safety and effectiveness on wounds that have been treated with LiquiBand®* XL and then exposed for prolonged periods to direct sunlight or tanning lamps have not been studied.

Safety and effectiveness of LiquiBand®* XL liquid adhesive on wounds in vermilion surfaces have not been studied.

LiquiBand®* XL should be used immediately after crushing the glass ampoule as the liquid adhesive will not flow freely from the applicator tip after a few minutes.

Hold the applicator away from yourself and the patient and break the ampoule using the wings. Do not crush the contents of the applicator tube repeatedly as excessive manipulation of the applicator may cause glass shard penetration.

Adverse reactionsClinical use of cyanoacrylate with adjunct wound closure devices has suggested that the following adverse events may occur:

Infection (redness more than 3 to 5 mm from the wound margin, swelling, purulent discharge, pain, increased skin temperature, fever)

Acute inflammation (erythema, edema, drainage, pain, warmth)

Dehiscence

Bleeding

Skin edge necrosis

Excessive itching

Skin blistering

Seroma

Hematoma

Bonding to unintended tissues such as the eye

Thermal discomfort during polymerization

Allergic reaction

Foreign body reaction

Chronic non-healing of a wound

SwiftSet™* topical skin adhesive

SwiftSet™* topical skin adhesive is a butyl cyanoacrylate adhesive with a 30-second polymerization time and unique precision tip attachment.

Indications, Safety, and WarningsIndications SwiftSet™* topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. SwiftSet™* topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.Contraindictions

Do not use on any wounds with evidence of active microbial, bacterial, or fungal infections or gangrene.

Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids.

Do not use on patients that have a hypersensitivity to cyanoacrylates or formaldehyde.

Do not apply internally, inject intravascularly, or ingest.

Do not use on decubitus ulcers, animal or human bite wounds, or stab wounds.

Warnings

SwiftSet™* topical skin adhesive is a fast-setting adhesive capable of adhering to most body tissues and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, surface and/or equipment that is not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided.

Polymerization of SwiftSet™* topical skin adhesive may be accelerated by water or fluids containing alcohol. SwiftSet™* topical skin adhesive should not be applied to wet wounds.

SwiftSet™* topical skin adhesive should not be applied to the eye. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.

When closing facial wounds near the eye using SwiftSet™* topical skin adhesive, adjust the patient’s position so that any flow of the adhesive is away from the eye. The eye should be closed and protected with gauze. Strategic placement of petroleum jelly near the eye can be effective at preventing inadvertent flow of the adhesive into the eye. Use of adhesives near the eye has inadvertently caused some patients’ eyelids to be sealed shut. In some of these cases, general anesthesia and surgical intervention has been needed to open the eyelid.

SwiftSet™* topical skin adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where SwiftSet™* topical skin adhesive is intended to adhere.

SwiftSet™* topical skin adhesive is not absorbable and therefore should not be used below the skin as it may cause a foreign body reaction.

SwiftSet™* topical skin adhesive should not be used in areas with high or increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or the skin tension has been decreased by application of another would closure device (e.g., sutures or skin staples) prior to application of SwiftSet™* topical skin adhesive.

Wounds treated with SwiftSet™* topical skin adhesive should be monitored for signs of infection. Wounds with signs of infection such as erythema, edema, warmth, pain, and/or drainage should be evaluated and treated according to standard practice for infection.

SwiftSet™* topical skin adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.

SwiftSet™* topical skin adhesive should be used only on wounds that have easily apposed edges which have been thoroughly cleaned, debrided, and otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to ensure adequate cleansing and debridement.

SwiftSet™* topical skin adhesive should always be applied sparingly, either as minute drops or as a thin film bridging the wound and the aligned wound edges. Avoid pressure on the applicator to prevent wound edge separation, which could cause the topical skin adhesive to be interposed between the wound edges. Application and/or migration (leak) of the topical skin adhesive below the surface of the skin and between the wound edges may impair the healing process by forming a barrier.

SwiftSet™* topical skin adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying SwiftSet™* topical skin adhesive sparingly in minute drops or a thin film onto a dry wound, heat is released slowly, and the sensation of heat or pain experienced by the patient is minimized. However, if SwiftSet™* topical skin adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort.

SwiftSet™* topical skin adhesive is packaged for a single patient use. Discard remaining opened material after each wound closure procedure.

Do not re-sterilize SwiftSet™* topical skin adhesive or include it in a procedure pack/tray that is to be sterilized prior to use. Exposure of SwiftSet™* topical skin adhesive, after its final manufacture, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam), is known to increase viscosity and may render the product unusable.

Precautions

This product is meant for external dermal application only.

Safety and effectiveness of SwiftSet™* topical skin adhesive has not been evaluated for use on wounds of patients with uncontrolled diabetes mellitus, diseases, or conditions that are known to interfere with the wound healing process, or a personal or family history of keloid formation or hypertrophic scarring.

Safety and effectiveness has not been evaluated on wounds that have been treated with SwiftSet™* topical skin adhesive and then exposed for prolonged periods of time to direct sunlight or tanning lamps.

SwiftSet™* topical skin adhesive permeability by topical medications or other fluids is not known and has not been studied.

Liquid, ointment, or cream medications should not be applied to the wound after closure with SwiftSet™* topical skin adhesive, as these substances may weaken the polymerized film which may allow for wound dehiscence.

If unintended bonding of intact skin with SwiftSet™* topical skin adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine^®*, or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

SwiftSet™* topical skin adhesive is a viscous liquid prior to polymerization. To prevent inadvertent flow of SwiftSet™* topical skin adhesive to unintended areas: The wound should be placed in a horizontal position, with SwiftSet™* topical skin adhesive applied from above. SwiftSet™* topical skin adhesive should be applied in minute drops or as a thin film rather than in a few large droplets. Do not attach precision tip after using broad tip as adhesive may get transferred to hand and applicator body.

Do not attach precision tip after using broad tip as adhesive may get transferred to hand and applicator body.

Adverse reactions Clinical use of cyanoacrylate-based topical skin adhesives has suggested that the following adverse events may occur: wound dehiscence; infection; acute inflammation including erythema, edema and drainage; bonding to unintended tissues such as the eye; thermal discomfort during polymerization; allergic reaction; foreign body reaction; and chronic non-healing of a wound.TM* Third-party brands are trademarks of their respective owners.®* Third-party brands are trademarks of their respective owners.

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† Bench test results may not be indicative of clinical performance.

‡ As compared to conventional sutures.

§ Based on surgeon / customer validation.

◊ Measured by straight pull strength.

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