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(opens new window).
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
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 Physician’s 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(opens new window).
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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
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
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 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 Physician’s 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.(opens new window)
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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
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
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 Physician’s 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(opens new window).
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Engineered to cross tight lesions and provide better deliverability*
5 Fr compatible
(4–6 mm diameter)
130 and 200 cm catheter lengths provide the option of transradial† or femoral access
Uses the same proven formulation as IN.PACT™ Admiral™, the DCB physicians choose the most
Features
Platinum-iridium marker bands
Coaxial shaft
FreePac™ coating
130 and 200 cm catheter lengths
Peel-away balloon protector
The IN.PACT 018 DCB features a peel-away balloon protector that helps preserve the integrity of the drug coating.
Expanded platform, trusted data
The Medtronic IN.PACT 018 and IN.PACT Admiral DCBs allow you to choose your preferred tool, knowing you're using DCBs backed by unmatched safety and efficacy data1 — including five-year data on complex lesions.2
With 75% of patients remaining reintervention-free at five years,1 IN.PACT Admiral has the:
Highest patency benefit through three years1
Lowest CD-TLR rate through five years1
Most publications for a DCB‡
The safety and effectiveness of the IN.PACT Admiral DCB (.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. The IN.PACT 018 DCB has not been evaluated in a clinical study.
Clinical case review
Watch Dr. Jun Li, Dr. Peter Monteleone, and Dr. Sameh Sayfo discuss challenging cases where IN.PACT 018 was used after vessel preparation.
The physician panel also discusses:
Treating the SFA and popliteal via radial† access using IN.PACT 018 DCB's 200 cm catheter
The use of directional atherectomy followed by DCB
Impact of paclitaxel safety on physician practices
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IN.PACT 018 DCB Product Workshop Video
- (33:08)
Watch Dr. Jun Li , Dr. Peter Monteleone, and Dr. Sameh Sayfo discuss challenging cases where IN.PACT 018 drug-coated balloon (DCB) was used after vessel preparation.
More information (see more)Less information (see less)
Building on proven technology
The IN.PACT 018 DCB uses the same proven formulation as IN.PACT Admiral DCB, so interventionalists can expand their treatment options without compromising on safety and effectiveness.
IN.PACT DCBs are coated with a combination of paclitaxel and an excipient, urea. The unique formulation allows rapid and efficient delivery of drug to the vessel wall.
Watch this mechanism of action animation to see what makes IN.PACT DCBs unique.
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Backed by proven technology, the IN.PACT Admiral and IN.PACT 018 DCB Outcomes Protection Program is one of the ways we are partnering with you to improve patient outcomes, manage costs, and advance value-based healthcare.
We’re so confident in our clinical outcomes that we will share in the cost of care if your patients require reintervention within one year of treatment.
24-hour technical support (worldwide) 763-514-4000
The safety and effectiveness of the IN.PACT Admiral DCB (.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. The IN.PACT 018 DCB has not been evaluated in a clinical study.
*
Data on file with Medtronic.
†
Complications associated with radial access may include but are not limited to: abrupt vessel closure, vessel spasm, perforation or rupture of the artery, dissection, pseudoaneurysm, hematoma, thrombosis, and stroke.
‡
Publications on file with Medtronic.
§
Some restrictions may apply.
References
1
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.
2
Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA 2021.
