Alert Indications, Safety, and Warnings

IN.PACT Admiral Drug-Coated Balloon Paclitaxel-coated Balloon

The IN.PACT™ Admiral™ drug-coated balloon (DCB) is a clinically proven, primary endovascular therapy that treats femoropopliteal disease, reduces reinterventions, and preserves future treatment options.1 The IN.PACT Admiral DCB is indicated for de novo, restenotic, or in-stent restenotic lesions up to 360 mm with reference vessel diameters of 4 to 7 mm in the superficial femoral or popliteal arteries.

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Alert Indications, Safety, and Warnings

Overview

Market-leading Drug-coated  Balloon 

For treatment of femoropopliteal disease with 75% of patients reintervention-free at 5 years.1 This matters now more than ever.†

IN.PACT Admiral drug-coated balloon shown in 150, 200, and 250 mm lengths

Now Backed By 5-year IDE and Global Study Data2

Product Details

Maintain long-term vessel patency with the IN.PACT Admiral drug-coated balloon (DCB), which provides durable, consistent, and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. With more than 3,500 patients enrolled in 21 clinical studies and 500,000+ patients treated worldwide, the IN.PACT Admiral balloon is the market-leading DCB for treatment of femoropopliteal disease.

The IN.PACT Admiral DCB is a clinically proven, primary endovascular therapy that treats femoropopliteal disease, reduces interventions, and preserves future treatment options. 

Duration of Paclitaxel In Tissue

Only the IN.PACT Admiral DCB releases drug into the tissue through the restenotic window.

Only the IN.PACT Admiral drug-coated balloon releases drug into the tissue through the restenotic window

IN.PACT Admiral DCB, with sustained drug in tissue up to 180 days,5 has the:   

Highest patency benefit through 3 years.‡6

Lowest CD-TLR and mortality rates through 5 years.1,7

Most publications for a DCB.§

How It Works

IN.PACT Admiral Drug-Coated Balloon Mechanism of Action

See how the DCB works.

DCB: Decades of Development

DCB therapies have been around since 2001, when Dr. Bruno Scheller and Dr. Ulrich Speck envisioned combining mechanical dilatation from PTA with restenosis inhibition from a drug into a single device.

Watch the evolution from concept into a frontline therapy for PAD.

Model Specifications

Feature

Specifications

Paclitaxel Drug Dose

3.5 µg/mm2

Excipient

Urea

Balloon Diameters

4.0 to 7.0 mm

Balloon Lengths

40, 60, 80, 120, 150, 200, and 250 mmll

Balloon Fold Configurations

4.0 mm: 3 folds; 5.0, 6.0, and 7.0 mm: 6 folds

Catheter Design

Over-the-wire (OTW)

Catheter Lengths

80 and 130 cm

Guidewire Compatibility

0.035 in

Ordering Information 

Model Number

(80 cm Catheter)

Model Number

(130 cm Catheter)

Balloon Diameter

(mm)

Balloon Length

(mm)

Recommended Introducer

Sheath (F)

Nominal Pressure

(atm)

RBP

(atm)
ADM 040 040 08P ADM 040 040 13P 4.0 40 5 8 14
ADM 040 060 08P ADM 040 060 13P 4.0 60 5 8 14
ADM 040 080 08P ADM 040 080 13P 4.0 80 5 8 14
ADM 040 120 08P ADM 040 120 13P 4.0 120 5 8 14
ADM 040 150 08P ADM 040 150 13P 4.0 150 5 8 14
ADM 040 200 08P ADM 040 200 13P 4.0 200 5 5 11
ADM 040 250 08P ADM 040 250 13P 4.0 250 5 5 11
ADM 050 040 08P ADM 050 040 13P 5.0 40 6 8 14
ADM 050 060 08P ADM 050 060 13P 5.0 60 6 8 14
ADM 050 080 08P ADM 050 080 13P 5.0 80 6 8 14
ADM 050 120 08P ADM 050 120 13P 5.0 120 6 8 14
ADM 050 150 08P ADM 050 150 13P 5.0 150 6 8 14
ADM 050 200 08P ADM 050 200 13P 5.0 200 6 5 11
ADM 050 250 08P ADM 050 250 13P 5.0 250 6 5 11
ADM 060 040 08P ADM 060 040 13P 6.0 40 6 8 14
ADM 060 060 08P ADM 060 060 13P 6.0 60 6 8 14
ADM 060 080 08P ADM 060 080 13P 6.0 80 6 8 14
ADM 060 120 08P ADM 060 120 13P 6.0 120 6 8 14
ADM 060 150 08P ADM 060 150 13P 6.0 150 6 8 14
ADM 060 200 08P ADM 060 200 13P 6.0 200 6 5 11
ADM 060 250 08P ADM 060 250 13P 6.0 250 6 5 11
ADM 070 040 08P ADM 070 040 13P 7.0 40 7 8 14
ADM 070 060 08P ADM 070 060 13P 7.0 60 7 8 14
ADM 070 080 08P ADM 070 080 13P 7.0 80 7 8 14

See the product catalog for complete, detailed product information.

Additional Resources

Manual and Technical Guides

Instructions for manual use

Find this technical manual in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling Medtronic at 1-763-526-7890.

Contact Us

CardioVascular LifeLine Customer Support

1-763-526-7890
rs.cstechsupport@medtronic.com

Orders

1-763-514-8510

24-hour Technical Support

1-763-514-4000
(Worldwide)
*

™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

†

The potential for fewer visits to a healthcare provider may reduce exposure to COVID-19-related risks.

‡

Primary patency not assessed after three years.

§

Data and additional comparative data on file with Medtronic.

||

120, 150, 200, and 250 mm lengths are not offered on the 7.0 mm diameter balloon.

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

IN.PACT Global Study 5-year Outcomes Full Clinical Cohort. Zeller, T. VIVA 2020.

3

Gongora CA, Shibuya M, Wessler JD, et al. Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. JACC Cardiovasc Interv. July 2015;8(8):1115-1123.

4

Spectranetics Stellarex 035 DCB Advisory Panel Briefing Package. June 2019.

5

Virmani R. Arterial wall response to drug coated balloon. Presented at Charing Cross 2016.

6

Schneider PA, Laird J, Tepe G, et al. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. January 2018;11(1):e.005891.

7

Based on the mortality data from the LEVANT 2 IDE in the Lutonix™* DCB IFU (BAW1387400r6) and the IN.PACT SFA Trial in the IN.PACT™ Admiral™ DCB IFU (M052624T001).