Medtronic’s In.Pact AV Drug-Coated Balloon Effectively Treats Hemodialysis Access Lesions In Trial
The In.Pact AV paclitaxel-coated balloon outperformed plain angioplasty balloons in the IN.PACT AV Access trial, the first large, multi-center randomized trial comparing a drug-coated balloon to standard balloon angioplasty in the treatment of hemodialysis arteriovenous access stenoses.
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Avenu’s Ellipsys vascular access system is an ultrasound-guided catheter to create a durable arteriovenous fistula for patients undergoing dialysis.
November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.
A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.