Medtronic’s IN.PACT AV Drug-Coated Balloon Receives the US FDA’s Approval for the Treatment of Arteriovenous Fistula Lesions

Medtronic’s IN.PACT AV Drug-Coated Balloon Receives the US FDA’s Approval for the Treatment of Arteriovenous Fistula Lesions

Shots:

  • The US FDA approval is based on IDE study assessing IN.PACT AV DCB vs percutaneous transluminal angioplasty in 330 patients with end-stage renal disease (ESRD) undergoing dialysis at 29 sites in the US, Japan, and New Zealand
  • The study showed that IN.PACT AV DCB maintained AV access site patency and required 56% fewer reinterventions @6mos., similar mortality rate @12mos., later demonstrated superior patency in both de novo and restenotic lesions and all studied types of AV access
  • Medtronic’s IN.PACT AV DCB utilizes its Admiral platform act by increasing the blood flow and reducing thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel and has received CE Mark indication in 2016

Click here to­ read full press release/ article | Ref: Medtronic | Image: Vascular News