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Medtronic, Bard In Close Race To First FDA-Approved Drug-Eluting Balloon

This article was originally published in The Gray Sheet

Executive Summary

Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.

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