FDA approves IN.PACT AV drug-coated balloon to treat arteriovenous fistula lesions.- Medtronic

Medtronic plc 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.

The IN.PACT AV DCB is a clinically demonstrated endovascular therapy for End Stage Renal Disease (ESRD) patients with a narrowed AV fistula. It delivers an antiproliferative drug (paclitaxel) to the vessel to inhibit neointimal hyperplasia (NIH), the primary cause of AV fistula stenosis. The proprietary design enables the IN.PACT AV DCB to deliver sustained drug levels and unparalleled clinical results.

Comment:People with non-functional kidneys who undergo dialysis receive AV fistulae, which link an artery to a vein. Veins tend to be too fragile for regular access, but arteries are too deep. Creating an AV fistula makes the connected vein much more resilient and capable of providing vascular access for dialysis. Eventually, AV fistulae tend to fail because of restenosis, limiting blood flow, and have to be expanded. This is a frequent procedure that comes with dangers, costs, and discomfort. The new Medtronic IN.PACT AV drug-coated balloon is designed to treat restenosis within AV fistulae and to increase the time between such maintenance procedures.