FDA Approval of Medtronic Drug-Coated Balloon

IN.PACT AV DCB Product Photo, Courtesy of Medtronic

It reduces reinterventions, and maintains access for end-stage renal disease for patients that have to undergo dialysis. This is what the clinical information highlighted for Medtronic’s latest product in the drug-coated balloon market, the IN.PACT AV DCB.

The IN.PACT AV DCB delivers a proven anti-proliferative drug paclitaxel. This delivery increases the flow of blood and reduces the vessel wall from thickening. By penetrating into the vessel walls, restenosis is prevented, which can potentially increase the time between interventions. Medtronic’s device was appointed the CE Mark for treating failing arteriovenous (AV) access in patient with end-stage renal disease undergoing dialysis

According to iData Research, Restenosis is common following plain-old balloon angioplasty (POBA). Primary patency rates following DCB procedures are significantly higher than POBA. The superior clinical outcomes of DCBs like Medtronic’s IN.PACT AV DCB are favourable. Continued development in the drug coated balloon segment of the peripheral vascular market can expect to drive growth.  

“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,” said Vincent Gallo, M.D., interventional radiologist at Holy Name Medical Center in Teaneck, New Jersey and an investigator for the IN.PACT AV Access trial. “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.”

“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 superficial femoral artery,” said Mark Pacyna, vice president and general manager of the Peripheral Vascular business in the Medtronic 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.”

For Further Information
To get in an in-depth market overview of 19 countries, with insight through primary research and procedural volumes, please read iData Research’s’ 2,958 page Peripheral Vascular Devices Market Analysis, Size and Trends Report.

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