Medtronic Completes Enrollment in IN.PACT SFA I DEB Study

May 16, 2011—At the EuroPCR 2011 conference in Paris, Medtronic, Inc. (Minneapolis, MN) announced recent developments from its clinical program for the In.Pact drug-eluting balloon (DEB) technology.

Enrollment was completed in the IN.PACT SFA I study on April 29. IN.PACT SFA I is a prospective, multicenter, randomized study comparing the In.Pact Admiral DEB to standard balloon angioplasty for treating de novo and restenotic lesions in the superficial femoral artery and proximal popliteal artery. The study enrolled 150 patients at 13 sites in Europe. The primary safety endpoint is a composite of 30-day death or target limb major amputation or clinically driven target vessel revascularization within 12 months. The primary efficacy endpoint is primary patency within 12 months.

Gunnar Tepe, MD, is the principal investigator of the trial, which forms the basis for the upcoming global IN.PACT SFA II study. The company announced that John Laird, MD, and Peter Schneider, MD, will be the principal investigators of SFA II.

“These groundbreaking trials on drug-eluting balloons will help build the evidence base for this promising therapeutic technology,” commented Dr. Tepe. “Drug-eluting balloons may represent the next-generation therapy for lower extremity vascular disease, as the devices allow interventionists to treat patients without placing a permanent implant and maintain future treatment alternatives. Medtronic is clearly leading this exciting field with its In.Pact technology and family of clinical trials.”