Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon can extend the time between reinterventions by maintaining arteriovenous access site patency, therefore, maximising a patient’s uninterrupted access to lifesaving dialysis care.
The FDA approval is based on data from a prospective, global, multicentre, blinded, randomised, investigational device exemption (IDE) study, which enrolled 330 patients, and evaluated the safety and effectiveness of the IN.PACT AV drug-coated balloon at 29 sites in the USA, Japan, and New Zealand.
The press release states that early data presented at the Cardiovascular Interventional Radiological Society of Europe (CIRSE; 7-11 September, Barcelona, Spain) met the primary endpoints in demonstrating the comparable safety and the superior effectiveness of IN.PACT AV drug-coated balloon compared to percutaneous transluminal angioplasty. Patients treated with IN.PACT AV drug-coated balloon maintained patency longer and required 56% fewer reinterventions compared to those treated with standard percutaneous transluminal angioplasty through six months. Through 12 months the data also showed no difference in mortality rates between the IN.PACT AV drug-coated balloon group and the percutaneous transluminal angioplasty control group.
Additionally, the press release reports that data presented at VIVA 2019 (2–7 November, Las Vegas, USA) demonstrated superior patency was achieved with IN.PACT AV drug-coated balloon versus percutaneous transluminal angioplasty in both de novo and restenotic lesions, and all studied types of arteriovenous access.
Vincent Gallo (Holy Name Medical Center, Teaneck, USA), an investigator for the IN.PACT AV Access trial, says: “In many cases, AV fistula are considered lifelines for patients with end-stage renal disease 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. 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.”
IN.PACT AV drug-coated balloon, leveraging technology from Medtronic’s IN.PACT Admiral platform, is designed to increase blood flow and reduce thickening of the vessel wall by delivering the anti-proliferative drug paclitaxel. The aim is for the drug to penetrate deep into the vessel wall to prevent restenosis and has the potential to extend time between reinterventions. In 2016, the CE mark indication for IN.PACT Admiral drug-coated balloon was expanded for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.
Mark Pacyna, vice president and general manager of the Peripheral Vascular business in the Medtronic Cardiac & Vascular Group, says: “The FDA approval of IN.PACT AV drug-coated balloon marks a significant step forward for paclitaxel-coated devices. Importantly, it allows us to expand our proven IN.PACT drug-coated balloon platform beyond the superficial femoral artery. We are excited to bring this technology to physicians in the U.S. and to help improve the lives of patients living with end-stage renal disease.”