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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Overview
Only Device to Achieve > 80% Primary Patency* Through Six Months
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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
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 DATAHow 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
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
Additional Resources
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
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.