Drug-Eluting Balloon One Step Closer to FDA Submission as Medtronic Completes Enrollment for IN.PACT Study

Medtronic, Inc. (NYSE: MDT) announced today that its IN.PACT drug-eluting balloon clinical program had reached the enrollment needed to support submission to the FDA for approval to use this novel device in the treatment of peripheral disease, specifically blockages in the superficial femoral artery. Although the IN.PACT family of drug-eluting balloons (DEB) have been available in Europe for over four years, no drug-eluting balloons have been approved for use in the United States.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news