Indications, Safety, and Warnings

Pillar System for the Pillar Procedure

Indications

The Pillar^® System (“System”) is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals, and for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).

Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction caused by the soft palate. The System is labeled for use by physicians and dental professionals with adequate training including maxillofacial surgeons

Contraindications

The System should not be used in the treatment of patients:

• Whose soft palate length, as measured from the hard palate junction to the base of the uvula, is <25mm.
• Under the age of 18.

Do not use substances that are incompatible with any of the product’s components (see Product Description/Components section).

Product Description/ Components

The System consists of a Delivery Tool and an Implant. The Delivery Tool comes preloaded with the Implant. The Implant is a braided segment of polyester filaments intended for permanent implantation. The Implant is approximately 18mm in length and has an approximate outer diameter of 2 mm. The Delivery Tool consists of a handle and 14- gauge needle. The needle is inserted into the soft palate; the Implant is deployed by advancing the slider; and the Delivery Tool is removed. The Delivery Tool is disposable.

Potential Complications

Use of the System involves potential risks normally associated with the use of any implanted device, including but not limited to, those listed below: 

• Difficulty swallowing
• Erosion of implant
• Gastro-intestinal obstruction
• Implant aspiration
• Implant rejection
• Implant migration
• Infection
• Mucosal edema
• Partial/full extrusion of Implant*
• Sore or scratchy throat
• Voice/taste change
• Allergic reaction to implant material
• Foreign body sensation

*Partial extrusions of the implant did occur during clinical studies, and patients should be informed of this potential complication.

Warnings

• Single use only. Do not resterilize.
• Sterile conditions should be maintained at all times while handling the System.
• Implant should not be removed from needle and/or modified prior to use.
• Do not use excessive force during needle insertion, implant deployment, or delivery tool removal.
• If the implant is ejected from the needle prior to placement, discard the implant and delivery tool.
• After use, all components should be treated as biologically hazardous waste during disposal.
• Product that is damaged, or where the sterility has been compromised should be returned - Contact Medtronic for detailed instructions.
• Should the implant require removal or the patient request removal, a minimally invasive surgical procedure is required.
• The insertion of the implant should only be undertaken by those physicians who have a comprehensive knowledge of the indications, techniques and risks of the procedure.

Cautions

Avoid inserting into the uvula or too far laterally as the palate is usually thinner in this area and subsequent partial/full extrusion of the Implants may occur.

Attempting to place the Implant into a pathway that has a breach on the nasopharyngeal aspect of the palate may result in extrusion of the Implant.

If the Implant is visible, it has been placed too superficially and must be removed and replaced with a new Implant. Implants placed too superficially may result in partial or full extrusions. DO NOT reposition the needle in the original penetration site.

Repose System – Tongue Suspension Procedure

Indications

The Repose^® Tongue Suspension procedure is intended for anterior advancement and suspension of the tongue base by means of a bone screw with attached fused sutures. It is indicated for the treatment of Obstructive Sleep Apnea (OSA) and/or snoring.

Contraindications

Contraindications associated with the Repose^® Tongue Suspension procedure include:

1. Primary palatal level of obstruction (Friedman Stage 1)
2. Marked macroglossia and severe tongue grooving based on oropharyngeal endoscopy
3. Abnormalities of the mandibular bone, severe periodontitis or poor oral hygiene.
4. History of myocardial infarction, stroke, congestive heart failure or central sleep apnea.
5. Blood coagulation disorders.
6. General anesthesia contraindications.
7. Prior head and neck radiation therapy.
8. Root canal dentistry for midline mandibular incisors

Warnings

1. Do not use if package is Open or Damaged
2. The optimal advancement of the posterior tongue base should be between 0.5-1.0 cm. Over advancement may lead to tongue edema and post procedure pain.
3. Do not reuse.
4. Verification that the knot is completely buried in the muscle must be performed.

Precautions

1. Repose^® Tongue Suspension should be performed by trained physicians only.
2. The sterile packaging of the Repose^® Bone Screw Kit and/or Screw should be inspected for visible damage prior to use. Do not use if damage is evident or suspected.

Note: Ensure that the screw is seated firmly in the inserter ratchet head prior to placing in incision and driving the screw into the mandible. If not firmly seated, move switch to “Ready” and pull on suture tail until screw seats in inserter ratchet head then return to “Safe” and continue with normal implantation steps.

Complications

Complications associated with Repose^® Tongue Suspension include those associated with other tongue base suspension and advancement methods. These risks include: infection, tongue edema, osteomyelitis, and neurovascular damage due to penetration of the suture passer through the lateral tongue base. Wharton’s duct and sublingual salivary gland damage (intraoral approach), damage to the teeth roots due to incorrect screw placement, relapse or over-correction of the tongue due to incorrect tightening of the sutures, muffled speech and suture breakage.

Repose System – Tongue and Hyoid Suspension Procedure

Indications

The Repose^® Tongue and Hyoid Suspension is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid suspension procedure as an adjunct to tongue base suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

Contraindications

1. Prior head and neck radiation
2. Abnormalities of the mandibular bone, severe periodontitis or poor oral hygiene, which may be indicative of compromised bone density.
3. History of myocardial infarction, stroke, congestive heart failure or central sleep apnea.
4. Blood coagulation disorders
5. General anesthesia contraindications
6. Site of obstruction other than tongue base or hypopharynx.
7. Compromised immune system.
8. Prior mandible fractures.

Warnings

1. Do not use if package is Open or Damaged
2. Do not reuse.

Precautions

1. The Repose^® Tongue and Hyoid Suspension should be used by trained physicians only.
2. The sterile packaging of the Repose^® Tongue and Hyoid Suspension should be inspected for visible damage prior to use. Do not use if damage is evident or suspected.
3. The physician is advised against using extreme traction when repositioning the hyoid to prevent the possibility of suture breakage.

Note: Ensure that the screw is seated firmly in the inserter ratchet head prior to placing in incision and driving the screw into the mandible. If not firmly seated, move switch to “Ready” and pull on suture tail until screw seats in inserter ratchet head then return to “Safe” and continue with normal implantation steps.

Complications

Complications associated with the Repose^® Hyoid Suspension procedure include those associated with other hyoid suspension procedures to either the mandible or thyroid cartilage. These risks include: infection, osteomyelitis, swallowing difficulty due to over-advancement of the hyoid bone and associated muscle, bone and suture breakage.

Straightshot M4 Microdebrider

The Straightshot M4 Microdebrider is part of the IPC^® System and XPS^® 3000 System.

Indications

IPC System:

The IPC^® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

IPC System:
None.

Warnings

IPC System:

WARNINGS

Indications

XPS 3000:

The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillornatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.

Contraindications

XPS 3000:
None.

Warnings

XPS 3000:

• Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
• Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
• Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
• Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
• Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
• Do not attach unapproved components to the XPS 3000 Console to avoid electrical macro shock.
• Carefully inspect burs prior to and following each use for excessive wear, fragmentation, eccentricities or other defects. Do not use dull, damanged or bent burs. Use of dull burs can reduce the handpiece effectiveness and cause the handpiece temperature to increase.
• Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
• Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
• Test for bur wobble (eccentricity) at desired speed prior to use. Use a bur guard (Xcalibur only) if needed. Select a new bur or reduce speed if wobble is observed.
• Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
• Keep the cooling sleeve irrigated to prevent thermal injury to tissue.
• During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
• For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
• Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
• Employ visualization when using rotating XPS accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
• Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
• Use lock on Straightshot M4 handpiece to prevent inadvertant rotation of blade or bur during use.
• When precise location of the blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on the Image Guided Surgery (IGS) system. Always lock the Straightshot M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
• Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
• Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
• Bending or prying may break the blade or bur, causing harm to patient or staff.
• Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
• Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.
• Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
• Disconnect power to the XPS 3000 Console before cleaning the unit to avoid electrical macro shock.
• After each procedure, properly clean all reusable system components.
• Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
• Remove and discard accessories following local regulations for proper disposal of contaminated materials.
• Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
• All service must be performed by Medtronic Xomed-qualified personnel only.

WARNINGS BEFORE SURGERY

• Verify reusable device was sterilized prior to use. If not sterilized, do not use.
• Do not use accessory if package is opened or damaged. Broken seal offers no protection against crosscontamination.
• Do not operate the XPS 3000 System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
• Achieve electrical grounding reliability with proper connections. Connect the XPS 3000 Console to hospital grade receptacles only.
• Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
• When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece.
• When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
• This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.

Straightshot Blades and Burs

Indications

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidectomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal/laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions and surgical management of recurrent respiratory papillomatosis (RRP).

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

Contraindications

None

Warnings

• DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
• For Airway Blades: Should the blade become clogged during use, risk assessment has determined 1-5 cc of irrigant could be aspirated by the patient before detection by the user.
• DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
• DO NOT use burs above the speed indicated on the bur label.
• For high speed drilling (greater than 6,000 rpm) ensure that an XPS High Speed Bur is used.
• Use adequate irrigation from a separate user-provided irrigating source. The use of an accessory without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
• Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination, use only once.
• Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
• Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
• Bending or prying may break the blade or bur, causing harm to patient or staff.
• Operate the blade or bur only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
• Blades, burs and irrigation tubing are disposable and intended for single-use only, UNLESS OTHERWISE MARKED.
• Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
• Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
• Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
• Employ visualization when using rotating XPS accessories, including use of image guided surgery system if needed. Discontinue powered application in the event of lack of visualization of the surgical site.
• Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
• Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
• Do not use any parts other than Medtronic system components as damage or substandard performance could result.
• Remove and discard accessories following local regulations for proper disposal of contaminated materials.
• Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
• Use lock on Straightshot M4 handpiece to prevent inadvertent rotation of blade or bur during use.
• It is important that the XPS 3000 operator be familiar with the system User’s Guide, its precautions, procedures, and safety issues.
• Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
• Excessive pressure applied to bur may cause bur fracture. Should a bur fracture occur during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.

Integrated Power Console (IPC System)

Indications

The IPC^® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

None.

Warnings

WARNINGS

PEAK PlasmaBlade TnA Device

View the Indications, Safety, and Warnings information for the PEAK PlasmaBlade™ TnA Device.