IN.PACT™ AV drug-coated balloon

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

Overview

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 It's the only device to achieve more than 80% primary patency^† through six months.

The IN.PACT™ AV paclitaxel-coated PTA balloon 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 mm to 12 mm.

Product 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, 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.^‡

See the data

Play Video

This will play a video. - View the IN.PACT™ AV drug-coated balloon introduction animation.

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

Play Video

This will play a video. - IN.PACT™ AV DCB Mechanism Of Action Video (Asia approved)

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

Additional resources

pdf Brochure: IN.PACT™ AV Drug-Coated Balloon (DCB) (.pdf)

4.8MB

pdf IN.PACT™ AV Access Clinical Trial Results (.pdf)

View the IN.PACT AV Access clinical trial results that demonstrate the highest reported primary patency in an AV DCB study.

618KB

pdf IN.PACT™ AV DCB Comparative Trial Results (.pdf)

View the results from separate trials comparing drug-coated balloons to standard PTA alone for AV fistula maintenance.

739KB

IN.PACT™ AV DCB Comparative Trial Results

pdf IN.PACT™ AV Patient Information Booklet (.pdf)

Download this patient information booklet, a helpful tool for understanding chronic kidney disease and the IN.PACT™ AV drug-coated balloon (DCB) for AV fistula maintenance.

7.6MB

IN.PACT™ AV trial results published

in the New England Journal of Medicine.

Review manuscript

Related resources

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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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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

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.

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.