Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints.
The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona on September 7.
The randomized, controlled trial included 330 subjects across 29 sites in the U.S., Japan and New Zealand. The patient population had been undergoing dialysis for an average of 4.3 years, according to Medtronic.
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