Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease.
The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint for the 330-patient study is patency of dialysis fistulas through 6 months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events.
Get the full story at our sister site, Drug Delivery Business News.
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