Medtronic closes enrollment in drug-eluting balloon study | MassDevice.com On Call

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MASSDEVICE ON CALL — Minneapolis-based medical device company Medtronic (NYSE:MDT) announced closed enrollment in the U.S. arm of a study evaluating its IN.PACT Admiral drug-eluting balloon.

The multi-center study enrolled 181 patients with peripheral artery disease at more than 40 U.S. clinics, randomizing them to either receive treatment with the IN.PACT Admiral or a traditional, non-coated angioplasty balloon.

Medtronic hopes to use the results from the trial in combination with data from IN.PACT SFA I to support a premarket approval bid, according to a press release.

The IN.PACT balloons have been on the market in Europe since 2008, but have yet to win FDA approval for the U.S. Medtronic plans to conduct a total of 24 IN.PACT studies involving about 4,000 patients in more than 80 countries, the company announced last year.

In October 2012 Medtronic closed enrollment in a clinical trial of its IN.PACT Amphirion drug-eluting balloon.

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