November 20, 2019
Medtronic's In.Pact AV DCB Approved by FDA to Treat Arteriovenous Fistula Lesions
November 21, 2019—Medtronic announced FDA approval of the In.Pact AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis.
Clinical trial data have shown that the In.Pact AV DCB can extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to dialysis care. The In.Pact AV DCB leverages technology from Medtronic’s In.Pact Admiral platform. In 2016, the European CE Mark indication for Medtronic’s In.Pact Admiral DCB was expanded for the treatment of failing AV access in patients with ESRD undergoing dialysis, noted the company.
According to the company, FDA approval is based on results from the pivotal IN.PACT AV Access trial. The prospective, global, multicenter, blinded, randomized (1:1), investigational device exemption study enrolled 330 patients and evaluated the safety and effectiveness of the In.Pact AV DCB at 29 sites in the United States, Japan, and New Zealand.
In September, Medtronic announced that early data from the trial were presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiological Society of Europe held September 7–11 in Barcelona, Spain. The trial met the primary endpoints in demonstrating the comparable safety and superior effectiveness of In.Pact AV DCB compared with percutaneous transluminal angioplasty (PTA).
In the IN.PACT AV Access trial, patients treated with the In.Pact AV DCB maintained patency longer and required 56% fewer reinterventions than those treated with standard PTA through 6 months. Through 12 months, the data showed no difference in mortality rates between the In.Pact AV DCB group and the PTA control group.
Additionally, data from a 6-month subgroup analysis from the IN.PACT AV Access trial were presented by Robert Lookstein, MD, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada. The data demonstrated that superior patency was achieved with the In.Pact AV DCB versus PTA in de novo and restenotic lesions, as well as all studied types of AV access.
“In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment,” commented Vincent Gallo, MD, an investigator for the IN.PACT AV Access trial, in the company’s announcement. “When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning. 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.” Dr. Gallo is an interventional radiologist at Holy Name Medical Center in Teaneck, New Jersey.
“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,” added Dr. Lookstein, National Principal Investigator of IN.PACT AV Access in the United States. “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.” Dr. Lookstein is Professor of Radiology and Surgery, Vice-Chair of Interventional Services, and Medical Director of Clinical Supply Chain at Mount Sinai Healthcare System in New York, New York.