View this booklet to learn about end-stage renal disease (ESRD) as well as treatment options with the IN.PACT™ AV drug-coated balloon.
Peripheral drug-coated balloons
IN.PACT™ AV drug-coated balloon
<p>The IN.PACT™ AV drug-coated balloon (DCB) is used for arteriovenous (AV) access maintenance.</p>
Explore the IN.PACT™ AV DCB.
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, 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
Clinical data
Get ahead of AV fistula restenosis.1
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.‡
† 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.
Risks may include: pain; hemorrhage; arterial or venous aneurysm/thrombosis, dissection, infection, perforation, or rupture; loss of permanent access; allergic/immunologic reaction; and death.
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
Frequently asked questions
Hemodialysis requires a way to gain access safely and repeatedly to your bloodstream. An AV fistula is the most common type of access. It connects an artery and a vein, typically in the arm, to increase blood flow for efficient dialysis and widen the vein for easier access.
IN.PACT™ AV drug-coated balloon can extend the time between reinterventions by approximately 14.7 months1 The IN.PACT™ AV DCB demonstrates 56% fewer reinterventions than PTA to maintain target lesion primary patency.1 It slows the progression of restenosis and minimizes post-treatment limitations of stents. See the clinical evidence page for more information.
IN.PACT AV drug-coated balloon is the first and only DCB with superior, sustained results at 36 months, compared to PTA.§,3,4 IN.PACT™ AV DCB demonstrated 43.1% target lesion primary patency at 36 months versus 28.6% for standard PTA, and 26.4% access circuit primary patency at 36 months versus 16.6% for standard PTA.3
§ Results from separate trials comparing drug-coated balloons to standard PTA for AV fistula maintenance. Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison.
An AV fistula provides a critical lifeline during dialysis treatment, but on average, patients require 1.5 maintenance procedures every year.5 In the largest randomized global DCB study published on AV fistula patients, the IN.PACT™ AV DCB reduced the need for reinterventions by more than half.1 People treated with IN.PACT™ AV DCB had 56% fewer fistula maintenance procedures through six months, compared to PTA.1
IN.PACT™ AV drug-coated balloon is coated with a drug called paclitaxel. A proprietary combination of paclitaxel drug and urea excipient allows rapid transfer of an antiproliferative drug to the vessel wall to inhibit neointimal hyperplasia (NIH), the primary cause of AV fistula stentosis.6 Reservoirs of paclitaxel can be sustained in the vessel wall for up to 180 days, delivering unparalleled clinical results.1,6,7 Only IN.PACT™ DCBs release drug into the tissue through the restenotic window, which is the time period the vessel is at highest risk of narrowing again.
IN.PACT™ AV drug-coated balloon is available in 80 cm and 130 cm catheter lengths. See the ordering information table for more details.
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
| 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 |
Related links
- 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.
- Lookstein RA, Haruguchi H, Suemitsu K, et al. IN.PACT AV access randomized trial of drug-coated balloons for dysfunctional arteriovenous fistulae: clinical outcomes through 36 months. J Vasc Interv Radiol. 2023;34(12):2093–2102.e7. doi:10.1016/j.jvir.2023.07.007.
- Trerotola SO, Saad TF, Roy-Chaudhury P, Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis. J Vasc Interv Radiol. 2020;31(1):1–14.e5. doi:10.1016/j.jvir.2019.08.035.
- Sorber R, Canner JK, Abularrage CJ, et al. Quantifying the costs of creating and maintaining hemodialysis access in an all-payer rate-controlled health system. Ann Vasc Surg. 2021;76:142–151. doi:10.1016/j.avsg.2021.05.008.
- Data on file at Medtronic in GLP preclinical study FS201.
- Lutonix™* 035 drug-coated balloon PTA catheter Model 9010 instructions for use.