Medtronic's Drug-Eluting Balloon Data for Peripheral Angioplasty Submitted to FDA

Medtronic, Inc. (NYSE: MDT) announced on Thursday that it had submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon (DEB), to be used in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. Medtronic reports that with submission of this data, it is on track to gain FDA approval in two years, which would make it the first drug-eluting balloon available in the U.S. for use in the treatment of peripheral disease.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news