Medtronic Reaches Milestone in Clinical Program for In.Pact Admiral Drug-Eluting Balloon

June 3, 2013—Medtronic, Inc. (Minneapolis, MN) announced that enough patients have been enrolled in its clinical studies of the In.Pact Admiral drug-eluting balloon to support the company's United States regulatory approval submission of the device, which is designed to treat atherosclerotic lesions in the superficial femoral artery (SFA). Medtronic also announced that it plans to submit the first module of the premarket approval (PMA) application for the In.Pact Admiral drug-eluting balloon to the US Food and Drug Administration (FDA) over the summer.

More than 1,000 patients have been enrolled in the IN.PACT SFA I, II, II pharmacokinetics (PK), and Global studies to date. Clinical data from these studies will be a significant portion of Medtronic's PMA application to the FDA for the In.Pact Admiral drug-eluting balloon. IN.PACT SFA I is a European study, IN.PACT SFA II and II PK are both United States studies, and IN.PACT Global is an international study being conducted outside the United States.

The ongoing global IN.PACT clinical program includes 29 studies involving more than 4,600 patients at approximately 230 sites worldwide. Through these company-sponsored and physician-initiated studies, Medtronic's In.Pact Admiral drug-eluting balloons will be investigated for the treatment of arterial disease in a variety of vessel beds. Medtronic is currently enrolling the IN.PACT Global study, a first-of-its-kind, real-world evaluation of the company's In.Pact Admiral drug-eluting balloons involving 1,500 patients with femoropopliteal lesions of any length at up to 80 sites worldwide.

In.Pact Admiral drug-eluting balloons, which feature a coating called FreePac that is a formulation of paclitaxel and urea, received CE Mark approval in 2008 and 2009 and are available in many countries around the world. In the United States, the In.Pact Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption granted by the FDA and is not yet commercially available, the company advised.