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Peripheral drug-coated balloons

IN.PACT™ AV drug-coated balloon

<p>The IN.PACT™ AV drug-coated balloon (DCB) is used for arteriovenous (AV) access maintenance.</p>

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Features

The IN.PACT™ AV DCB is a clinically demonstrated endovascular therapy for end-stage renal disease (ESRD) patients with a narrowed AV fistula. It delivers an antiproliferative drug (paclitaxel) to the vessel to inhibit neointimal hyperplasia (NIH), the primary cause of AV fistula stenosis. The proprietary design enables the IN.PACT™ AV DCB to deliver sustained drug levels and unparalleled clinical results.1

Efficient delivery

A proprietary combination of paclitaxel drug and urea excipient allows rapid transfer of the antiproliferative drug to the vessel wall.2

Sustained duration

Reservoirs of the drug stay in the vessel wall, making it capable of delivering effective paclitaxel levels by residing in the vessel for up to 180 days.2

Extended effect

Uniquely combining an appropriate dosage for an appropriate amount of time,2 the IN.PACT™ AV DCB can reduce the need for reinterventions and catheter-based dialysis and the related risks of infection and all-cause mortality.1

Specifications

Product characteristic Description
Balloon coating Paclitaxel and urea
Catheter shaft design Over-the-wire (OTW)
Sterilization method Ethylene oxide (ETO)
Shaft diameter 5 Fr
Catheter effective length 80, and 130 cm
Balloon lengths 40 to 120 mm
Nominal balloon pressure 4.0–9.0 mm — 8 atm; 10.0–12.0 mm — 6 atm
Rated burst pressure 4.0–7.0 mm — 14 atm; 8.0–9.0 mm — 10 atm; 10.0 mm — 9 atm; 12.0 mm — 9 atm
Balloon diameters 4.0 to 12.0 mm
Introducer sheath compatibility 4.0 mm — 5 Fr; 5.0–6.0 mm — 6 Fr; 7.0–10 mm — 7 Fr; 12.0 mm — 9 Fr
Balloon fold configuration 4.0 mm 3 folds; 5 — 12 mm 6 folds
Paclitaxel drug dose 3.5 μg/mm2
Guidewire compatibility 0.035"

Ordering information

Usable length 80 cm Usable length 130 cm Balloon diameter (mm) Balloon length (mm) Recommended introducer sheath (Fr) Nominal pressure (atm) RBP (atm)
IAV04004008P — 4 40 5 8 14
IAV04006008P — 4 60 5 8 14
IAV04008008P — 4 80 5 8 14
IAV04012008P — 4 120 5 8 14
IAV05004008P — 5 40 6 8 14
IAV05006008P — 5 60 6 8 14
IAV05008008P — 5 80 6 8 14
IAV05012008P — 5 120 6 8 14
IAV06004008P — 6 40 6 8 14
IAV06006008P — 6 60 6 8 14
IAV06008008P — 6 80 6 8 14
IAV06012008P — 6 120 6 8 14
IAV07004008P — 7 40 7 8 14
IAV07006008P — 7 60 7 8 14
IAV07008008P — 7 80 7 8 14
IAV08004008P IAV08004013P 8 40 7 8 10
IAV08006008P IAV08006013P 8 60 7 8 10
IAV08008008P IAV08008013P 8 80 7 8 10
IAV09004008P IAV09004013P 9 40 7 8 10
IAV09006008P IAV09006013P 9 60 7 8 10
IAV09008008P IAV09008013P 9 80 7 8 10
IAV10004008P IAV10004013P 10 40 7 6 9
IAV12004008P IAV12004013P 12 40 9 6 9

Related links

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† Target lesion primary patency in an AV fistula IDE randomized controlled trial.

‡ The largest global, randomized, AV fistula drug-coated balloon study conducted, with subjects from Japan, New Zealand, and the United States.

  1. Lookstein RA, Haruguchi H, Ouriel K, et al. IN.PACT™ AV access investigators. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 2020;383(8):733-742. Highlighted results reported at both 180 and 210 days.

  1. Data on file at Medtronic.

This product is licenced with Health Canada as "IN.PACT AV PACLITAXEL-COATED PTA BALLOON CATHETER" on Health Canada licence number "MDL#104501".