| 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 |
Peripheral drug-coated balloons
IN.PACT™ AV drug-coated balloon
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.
Description
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 used 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.
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
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
Related links
† 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.
- 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.
- 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".