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Medtronic: IN.PACT AV Access Trial Meets Primary Safety, Effectiveness Endpoints

Medtronic plc (MDT) announced the results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT AV drug-coated balloon or DCB to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous or AV fistulae lesions. The study met primary safety and effectiveness endpoints.

The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months post-procedure and the primary safety endpoint was defined as the serious adverse event rate involving the AV Access circuit through 30 days post-procedure.

Additional endpoints include but are not limited to: access circuit primary patency, cumulative target lesion revascularizations, and number of interventions required to maintain target lesion patency.

The company said, "IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients."

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