Healthcare Professionals

IN.PACT Admiral Drug-Coated Balloon

Paclitaxel-coated Balloon

Overview

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 200,000+ patients treated, the IN.PACT Admiral balloon is the market-leading DCB for treatment of femoropopliteal disease with 75% of patients reintervention-free at 5 years.1 This matters now more than ever.

Indications

Please note the Instructions for Use were updated recently to include enhanced information on paclitaxel safety. Please follow the “indications, safety, and warnings” link at the top of this page for more information.

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 up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm.

Product Details

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

IN.PACT Admiral DCB, with sustained drug release up to 180 days,2 has the:

  • Highest patency benefit through 3 years‡3
  • Lowest CD-TLR rates and lowest mortality through 5 years1,4
  • Most publications for a DCB§

HOW IT WORKS

DURATION OF PACLITAXEL IN TISSUE

Competitive comparison showing the duration of paclitaxel in tissue after an index procedure with IN.PACT Admiral DCB, Ranger DCB, Lutonix DCB and Stellarex DCB

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

IN.PACT Admiral Drug-Coated Balloon Mechanism of Action

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.

DCB: Decades of Development Video

Watch the evolution from concept into a frontline therapy for PAD.
More information (see more) Less information (see less)

Manuals and Technical Guides

Instructions for Use Manual
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. 

MODEL SPECIFICATIONS

TECHNICAL 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 mm
Balloon Fold Configuration 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"

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 product catalog for complete, detailed product information.

*

™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 3 years.

§

Data and additional comparative data on file with Medtronic.

||

Ranger™* DCB is not approved for commercial use in the United States.

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

References

1

Laird J, Schneider P, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. June 2019;12(6):e007702.

2

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

3

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.

4

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).

5

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.

6

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