Peripheral drug-coated balloons

IN.PACT™ AV drug-coated balloon

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

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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

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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

Get ahead of AV fistula restenosis1

In the largest randomized AV DCB study conducted,† IN.PACT™ AV DCB reduced interventions by more than 56% over PTA.1 It is the only AV DCB on the market to meet its primary effectiveness endpoint.‡

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How it works

Mechanism of action

The IN.PACT™ AV DCB is coated with a unique combination of paclitaxel, an antiproliferative drug, and an excipient, urea. The unique drug dose and excipient formulation showed unmatched results versus PTA in the largest AV DCB clinical trial.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 40, 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 40 cm Usable length 80 cm Usable length 130 cm Balloon diameter (mm) Balloon length (mm) Recommended introducer sheath (Fr) Nominal pressure (atm) RBP (atm)
IAV04004004P IAV04004008P — 4 40 5 8 14
IAV04006004P IAV04006008P — 4 60 5 8 14
IAV04008004P IAV04008008P — 4 80 5 8 14
IAV04012004P IAV04012008P — 4 120 5 8 14
IAV05004004P IAV05004008P — 5 40 6 8 14
IAV05006004P IAV05006008P — 5 60 6 8 14
IAV05008004P IAV05008008P — 5 80 6 8 14
IAV05012004P IAV05012008P — 5 120 6 8 14
IAV06004004P IAV06004008P — 6 40 6 8 14
IAV06006004P IAV06006008P — 6 60 6 8 14
IAV06008004P IAV06008008P — 6 80 6 8 14
IAV06012004P IAV06012008P — 6 120 6 8 14
IAV07004004P IAV07004008P — 7 40 7 8 14
IAV07006004P IAV07006008P — 7 60 7 8 14
IAV07008004P IAV07008008P — 7 80 7 8 14
IAV08004004P IAV08004008P IAV08004013P 8 40 7 8 10
IAV08006004P IAV08006008P IAV08006013P 8 60 7 8 10
IAV08008004P IAV08008008P IAV08008013P 8 80 7 8 10
IAV09004004P IAV09004008P IAV09004013P 9 40 7 8 10
IAV09006004P IAV09006008P IAV09006013P 9 60 7 8 10
IAV09008004P IAV09008008P IAV09008013P 9 80 7 8 10
IAV10004004P IAV10004008P IAV10004013P 10 40 7 6 9
IAV12004004P IAV12004008P IAV12004013P 12 40 9 6 9

Resources

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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.

§ Results are from different studies and may vary in a head-to-head comparison.

  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.