FDA OKs Medtronic's Paclitaxel Balloon to Help Maintain Dialysis Access

Megan Brooks

November 22, 2019

The US Food and Drug Administration (FDA) has approved Medtronic's IN.PACT AV DCB, a paclitaxel-coated balloon for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis.

"In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment. When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning," Vincent Gallo, MD, interventional radiologist at Holy Name Medical Center in Teaneck, New Jersey and an investigator for the IN.PACT AV Access trial, said in a news release from Medtronic.

"With this approval, physicians now have access to a safe and extremely effective therapy to slow the progression of restenosis, which results in fewer reinterventions and disruptions in care for these patients," said Gallo.

The safety and effectiveness of the IN.PACT AV DCB was shown in a prospective randomized study involving 330 patients from 29 sites in the United States, Japan, and New Zealand.

Through 6 months, patients treated with IN.PACT AV DCB maintained patency longer and required 56% fewer reinterventions compared with those treated with standard percutaneous transluminal angioplasty (PTA).

Superior patency was achieved with IN.PACT AV DCB vs PTA in both de novo and restenotic lesions, and all studied types of AV access.

Through 12 months, there was no difference in mortality rates between the IN.PACT AV DCB group and the PTA control group.

"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,” Robert Lookstein, MD, national principal investigator in the US and professor of radiology and surgery at Mount Sinai Healthcare System in New York City, said in the release.

"In the largest AV DCB pivotal study to date, IN.PACT AV DCB demonstrated the highest primary patency rate through 6 months and significantly lowered the rate of reinterventions required to maintain patency. 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," said Lookstein.

The FDA approved Medtronic's IN.PACT Admiral DCB (also coated with paclitaxel) to treat superficial femoral and popliteal arteries in 2014 and to treat in-stent restenosis in patients with peripheral artery disease (PAD) in 2016.

In 2018, the FDA expanded the indication for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360 mm in patients with PAD.

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