Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]
IN.PACT AV 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 [...]
The IN.PACT AV access clinical study, which is evaluating the investigational IN.PACT AV drug-coated balloon for the management of patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions, has met its primary safety and effectiveness endpoints. Data from the trial were presented today at the Cardiovascular and Interventional Radiology Society of Europe [...]