The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.

In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee. It has since received approval for indications in in-stent restenosis and long lesions (up to 360 mm).

$61M global market

AV fistulae are created by stitching together two veins, providing an access point for dialysis. Time, however, causes the fistula to narrow, a condition known as restenosis, which impedes the effectiveness of dialysis treatment. To remedy the problem and keep access sites open, patients face repeated procedures – often several per year – at considerable cost and delays in treatment. In.Pact AV is designed to preserve AV access site patency and reduce the number of those reinterventions.

Medtronic estimates the worldwide market for AV access is about $61 million, with $52 million of that in the U.S. The company expects to launch In.Pact AV before the end of 2019.

“The FDA approval of In.Pact AV DCB marks a significant step forward for paclitaxel-coated devices. Importantly, it allows us to expand our proven In.Pact DCB platform beyond the superior femoral artery,” said Mark Pacyna, vice president and general manager of the peripheral vascular business in Medtronic’s Cardiac & Vascular Group. “We are excited to bring this technology to physicians in the U.S. and to help improve the lives of patients living with ESRD.”

In.Pact AV Access trial

The FDA based its approval on the ongoing pivotal In.Pact AV Access trial. The prospective, multicenter, blinded, randomized IDE study is evaluating the In.Pact AV DCB in 330 patients at 29 sites in the U.S., Japan and New Zealand. Early results presented in September at the Cardiovascular and Interventional Radiology Society of Europe meeting in Barcelona, Spain, showed the device met both its primary endpoints of comparable safety and superior effectiveness, compared with percutaneous transluminal angioplasty (PTA).

Specifically, patients in the In.Pact AV group achieved an 86.1% primary patency rate of the target lesion at six months, vs. 68.9% for patients who underwent PTA. At seven months, the primary patency rate was 81.4% in the treatment arm and 59% for controls. In.Pact AV also cut down on reinterventions, requiring 56% fewer maintenance procedures through 210 days than were needed in the PTA group. On the issue of safety, In.Pact AV performed slightly better than PTA, with a 4.2% vs. 4.4% rate of access circuit-related serious adverse events.

“Until now, there were virtually no therapies available to treat AV fistulae lesions that had demonstrated an ability to maintain primary patency and reduce reinterventions over time,” said Robert Lookstein, national principal investigator in the U.S. for the In.Pact AV Access study and medical director of clinical supply chain at Mt. Sinai Healthcare System. “With this evidence and approval in hand, we now have a technology that provides a significant clinical benefit of a 56% reduction in repeat interventions, which I believe is a huge win for the hemodialysis community and the patients we treat.”

The In.Pact AV Access study will continue to evaluate patients through five years and is intended to support marketing authorizations in Japan and New Zealand as well. Both In.Pact Admiral and In.Pact AV are already available in CE mark jurisdictions.

Expanding field of competitors

Medtronic isn’t the only company this week to win FDA recognition for an AV fistula device. Merit Medical Systems Inc., of South Jordan, Utah, received a breakthrough device designation for its Wrapsody endovascular stent grant system. The company plans to seek FDA approval of the flexible, self-expanding endoprosthesis for use in hemodialysis patients to treat stenosis within the central veins of the outflow circuit of an AV fistula up to the superior vena cava. In its recent third-quarter earnings report, Merit said it had completed its first-in-human trial of the Wrapsody stent graft and was in discussions with the FDA for a pivotal study.

Tel Aviv-based startup Laminate Medical Technologies Ltd. is also focused on the space, with a U.S. pivotal IDE trial of its Vasq AV fistula device. The device is implanted external to an AV fistula in patients receiving hemodialysis and anchored to provide support for continued vascular access. Another contender in the AV fistula market is TVA Medical Inc., of Austin, with its Everlinq endoAVF system to improve fistula patency in patients with chronic kidney disease. The device, which is CE marked and licensed in Canada, employs a minimally invasive, catheter-based procedure to create a fistula with limited localized trauma.