Alert Indications, Safety, and Warnings

IN.PACT AV Drug-Coated Balloon
 for Arteriovenous (AV) Access Maintenance

The IN.PACT™ AV drug-coated balloon (DCB) enables you to get ahead of AV fistula restenosis by treating the cause — not just the symptoms — of fistula stenosis, helping to preserve the fistula for dialysis.1

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IN.PACT AV drug-coated balloon on a white background
Alert Indications, Safety, and Warnings

Overview

Only Device to Achieve > 80% Primary Patency*  Through Six Months 

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Illustration of IN.PACT AV drug-coated balloon in an AV fistula, red vessel on blue background

New England  Journal of Medicine Publishes Largest AV DCB  Pivotal Trial†

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Indications

The IN.PACT AV paclitaxel-coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

Product Details

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, 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

Play Video This will play a video - Image of the IN.PACT AV drug-coated balloon on a dark blue background

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.‡

SEE THE DATA

How it Works

Play Video This will play a video - Illustration of torso showing the common location for an AV fistula in the arm

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

Model Specifications

Product Characteristic Description

Balloon Coating

Paclitaxel and urea

Paclitaxel Drug Dose

3.5 μg/mm2

Balloon Diameters

4.0 to 12.0 mm

Balloon Fold Configuration

4.0 mm 3 folds; 5 — 12 mm 6 folds

Balloon Lengths

40 to 120 mm

Catheter Effective Length

40, 80, and 130 cm

Guidewire Compatibility

0.035"

Catheter Shaft Design

Over-the-wire (OTW)

Shaft Diameter

5 F

Introducer Sheath Compatibility

4.0 mm — 5 F; 5.0–6.0 mm — 6 F; 7.0–10 mm — 7 F; 12.0 mm — 9 F

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

Sterilization Method

Ethylene oxide (ETO)

Ordering Information

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pdf Clinical Trial Overview (.pdf)

IN.PACT AV Access Clinical Trial results

519KB

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IN.PACT AV Trial Overview Sell Sheet (US)
pdf Trial Comparison Sheet (.pdf)

Results from separate trials comparing DCBs to standard PTA alone for AV fistula maintenance

562KB

View Comparison
IN.PACT AV DCB Trial Comparative Sell Sheet (US)
pdf Patient Information Booklet (.pdf)

Patient guide for AV fistula maintenance

7.0MB

Download Guide
Drug-Coated Balloon Patient Guide for AV Fistula Maintenance

Additional Resources

IN.PACT AV TRIAL RESULTS PUBLISHED

in the New England Journal of Medicine.

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PRODUCT

MANUALS

Access product manuals from the Medtronic Manual Library by searching for the product name or product number.

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Contact Information

CardioVascular Lifeline Customer Support

+1-763-526-7890

rs.cstechsupport@medtronic.com

Orders

+1-763-514-8510

rs.cusvasorders@medtronic.com

24-hour Technical Support

+1-763-514-4000 (Worldwide)

*

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.

References

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. August 20, 2020;383(8):733-742. Highlighted results reported at both 180 and 210 days.

2

Data on file at Medtronic.

Reduction in reinterventions: Defined as the number of interventions required to maintain target lesion primary patency calculated at 210 days.