Your browser is out of date

With an updated browser, you will have a better Medtronic website experience. Update my browser now.

Indications, Safety, and Warnings

Indications, safety, and warnings
IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult with your physician. A prescription is required. For more information, please call Medtronic at 877-526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. This content is available electronically at manuals.medtronic.com.

IN.PACT Admiral and IN.PACT 018 DCB

Instructions for use

The IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter and IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter are indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm.

Contraindications

The IN.PACT Admiral DCB and IN.PACT 018 DCB are contraindicated for use in:

Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries.
Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy.
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
Patients with known allergies or sensitivities to paclitaxel.
Women who are breastfeeding, pregnant or are intending to become pregnant, or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings

A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2–3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.
Use the product prior to the Use-by Date specified on the package.
Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
Do not move the guidewire during inflation of the IN.PACT Admiral DCB or IN.PACT 018 DCB.
Do not exceed the rated burst pressure (RBP). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection. [IN.PACT Admiral DCB: The RBP is 14 atm (1419 kPa) for all balloons except the 200 and 250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115 kPa) – IN.PACT 018 DCB: The RBP is 10 atm (1013 kPa) for all balloons.]
The safety and effectiveness of using multiple IN.PACT Admiral DCB, or multiple IN.PACT 018 DCB, with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB. Vessel preparation using only pre-dilatation was studied in the IN.PACT Admiral DCB clinical studies. Other methods of vessel preparation, such as atherectomy, have not been studied clinically. The IN.PACT 018 DCB has not been evaluated in a clinical study.
The IN.PACT Admiral DCB and IN.PACT 018 DCB should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
The IN.PACT Admiral DCB and IN.PACT 018 DCB are designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
The safety and effectiveness of the IN.PACT Admiral DCB or IN.PACT 018 DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated.
The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
The use of the IN.PACT Admiral DCB and IN.PACT 018 DCB carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.
The IN.PACT Admiral DCB and IN.PACT 018 DCB are not intended for the expansion or delivery of a stent.

Potential adverse effects

The potential adverse effects (e.g., complications) associated with the use of the device are: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/ organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are not limited to: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion. Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy. Refer to the Physicians' Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time.

Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions, and potential adverse effects. This content is available electronically at manuals.medtronic.com.

CAUTION:Federal (USA) law restricts this device to sale by or on the order of a physician.

FTSOP113326-32 Rev. 1H

IN.PACT Admiral DCB

Indications for use

The IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm.

Contraindications

The IN.PACT Admiral DCB is contraindicated for use in:

Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Patients with known allergies or sensitivities to paclitaxel
Women who are breastfeeding, pregnant, or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings

A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2–3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.
Use the product prior to the Use-by Date specified on the package.
Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
Do not move the guidewire during inflation of the IN.PACT Admiral DCB.
Do not exceed the rated burst pressure (RBP). The RBP is 14 atm (1419 kPa) for all balloons except the 200 and 250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115 kPa). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
The safety and effectiveness of using multiple IN.PACT Admiral DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated.
The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.
Vessel preparation using only pre-dilatation was studied in the clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT Admiral DCB.
This product is not intended for the expansion or delivery of a stent.

Potential adverse effects

Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion. Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy. Refer to the Physicians' Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

IN.PACT 018 paclitaxel-coated PTA balloon catheter

Indications for use

The IN.PACT 018 paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm.

Contraindications:

The IN.PACT 018 DCB is contraindicated for use in:

Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Patients with known allergies or sensitivities to paclitaxel
Women who are breastfeeding, pregnant, or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings

A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2–3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.
Use the product prior to the Use-by Date specified on the package.
Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
Do not move the guidewire during inflation of the IN.PACT 018 DCB.
Do not exceed the rated burst pressure (RBP). The RBP is 10 atm (1013 kPa). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
The safety and effectiveness of using multiple IN.PACT 018 DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB. Vessel preparation using only pre-dilatation was studied in the IN.PACT Admiral DCB clinical studies. Other methods of vessel preparation, such as atherectomy, have not been studied clinically. The IN.PACT 018 DCB has not been evaluated in a clinical study.
This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
The safety and effectiveness of the IN.PACT 018 DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated.
The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.
This product is not intended for the expansion or delivery of a stent.

Potential adverse effects

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

UC201712493-05f EN

Tested. Trusted.
Market-leading drug-coated balloon

75% of patients treated with IN.PACT™ Admiral™ DCB remain reintervention-free at five years.¹

Alert Indications, Safety, and Warnings

Long-term outcomes

IN.PACT Admiral continues to demonstrate long-term clinical outcomes, even in patients considered to be at high risk of restenosis and repeat interventions.

Freedom from CD-TLR through five years:

74.5% IN.PACT SFA Trial¹
58.0% IN.PACT Global ISR Cohort²
67.3% IN.PACT Global Long Lesion Cohort²
69.8% IN.PACT Global CTO Cohort²

IN.PACT Admiral trials

IN.PACT Admiral DCB has the:

Highest patency benefit through three years compared to PTA^†1
Lowest CD-TLR rate through five years¹
Most publications for a DCB^‡

View the data

Proven formulation

The IN.PACT Admiral DCB features a proprietary FreePac^™ coating solution that allows for the release of drug into the tissue through the restenotic window.

Duration of paclitaxel in tissue
IN.PACT Admiral DCB provides 180 days of drug in tissue.^§3

Bar chart showing the number of days paclitaxel can be measured in tissue for IN.PACT Admiral, Lutonix, Ranger, and Stellarex

Download brochure

View product details

Impact on patient care

Watch Dr. Ehrin Armstrong speak about the benefits and clinical evidence to support IN.PACT Admiral as his DCB of choice.
More information (see more) Less information (see less)

Meet Robert Canterbury, who was diagnosed with peripheral artery disease (PAD), and see how IN.PACT Admiral DCB helped get him back on his feet.
More information (see more) Less information (see less)

Additional resources

Going the distance

See size options

Related resources

Connect with us

Reach a Medtronic sales rep
Contact us here

CardioVascular Lifeline
Customer Support
1-763-526-7890
rs.cstechsupport@medtronic.com

Orders
1-763-514-8510
rs.cuvasorders@medtronic.com

24-hour Technical Support
1-763-514-4000 (worldwide)

Third-party brands are trademarks of their respective owners.

^†

Primary patency not assessed after three years.

^‡

Publications on file with Medtronic.

^§

Data comes from different individual studies and may differ in a head-to-head comparison, and therefore may not be predictive of clinical results.

References

Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.

Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.

FDA. PMA P140010: Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140010. Accessed May 10, 2022.

⁴

FDA. PMA P190019: FDA Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019. Accessed May 10, 2022.

⁵

Virmani R. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. January 1, 2014;83(1):132-140.

⁶

FDA. PMA P160049: FDA summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160049. Accessed May 10, 2022.

Indications, safety, and warnings IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons

IN.PACT Admiral and IN.PACT 018 DCB

Instructions for use

Contraindications

Warnings

Precautions

Potential adverse effects

IN.PACT Admiral DCB

Indications for use

Contraindications

Warnings

Precautions

Potential adverse effects

IN.PACT 018 paclitaxel-coated PTA balloon catheter

Indications for use

Contraindications:

Warnings

Precautions

Potential adverse effects

Tested. Trusted. Market-leading drug-coated balloon

Long-term outcomes

Freedom from CD-TLR through five years:

IN.PACT Admiral DCB has the:

Proven formulation

Impact on patient care

Additional resources

Going the distance

Related resources

Connect with us

References

Indications, safety, and warnings
IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons

Tested. Trusted.
Market-leading drug-coated balloon