WE'VE EXTENDED OUR DCB RANGE

Introducing new longer lengths to our IN.PACT™ Admiral™ Drug-Coated Balloon range, to give you more options for treatment of longer, complex lesions.

New 200 mm - 250 mm lengths now available

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Illustration of DCBs showing the difference between using one long product instead of two standard sizes.

EXTRA LONG. EXTRA EFFICIENT.

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CLINICAL PERFORMANCE   HIGHEST PRIMARY PATENCY1 91.1%2 MEAN LESION LENGTH 26 CM

5 YEARS GOING STRONG

IN.PACT™ Admiral™ DCB provides up to 180 days of drug release in the tissue3, delivering:

  • Highest patency benefit through 3 years4,‡
  • Lowest CD-TLR rates and lowest mortality through 5 years3,5
  • Most publications for a DCB§

Duration of drug in tissue

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

75% OF PATIENTS REINTERVENTION-FREE AT 5 YEARS4

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technical specifications

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*

The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter.

Primary patency not assessed after 3 years.

Data on file UC202013694EE at Medtronic.

1

Based on clinical data for drug-coated balloons indicated to treat long SFA lesions (>180 mm): compared to Lutonix™* IFU BAW1387400r3. Per Stellarex™* IFU P011966-B, Stellarex is not indicated to treat lesions longer than 180 mm. Definitions of patency and lesion length may vary for different studies.

2

The IN.PACT Global Study Long Lesion Imaging Cohort D. Scheinert Circulation 2018.

3

IPA reference: PMA P140010: FDA Summary of Safety and Effectiveness Data

4

IN.PACT™ Admiral™ 5Y data: Laird JA, Schneider PA, 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.

5

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). Gongora CA, Shibuya M, Wessler JD, et al. Impact of 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

IPA reference: PMA P140010: FDA Summary of Safety and Effectiveness Data

7

Ranger Reference: PMA P190019: FDA Summary of Safety and Effectiveness Data

8

Lutonix Reference: 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. 2014 Jan 1;83(1):132-40.

9

Stellarex reference: PMA P160049: FDA Summary of Safety and Effectiveness Data