Medtronic Announces Plans for IN.PACT Global SFA Drug-Eluting Balloon Study

April 17, 2012—Medtronic, Inc. (Minneapolis, MN) announced that it will be commencing the IN.PACT Global superficial femoral artery (SFA) clinical study. The international, prospective, multicenter study will collect and assess safety and efficacy data on the company's In.Pact Admiral paclitaxel drug-eluting balloon (DEB) for the treatment of atherosclerotic disease in the SFA and/or popliteal arteries.

According to Medtronic, the study is designed to enroll up to 1,500 “real world” patients at up to 80 sites in numerous countries and will allow lesions of any length. Gunnar Tepe, MD, is Chair of the study's steering committee, which includes Marc Bosiers, MD; Do Dai Do, MD; Peter Gaines, MD; Alvaro Razuk, MD; and Gary Ansel, MD.

“By enrolling 1,500 unselected patients within the setting of a robust and controlled trial design like this, the Medtronic IN.PACT Global SFA study not only will provide first-of-its-kind results and insights on the role of drug-eluting balloons, but will also offer better and deeper understanding on ‘real-world' fem-pop disease, pattern, and its multiple variables,” commented Dr. Tepe. “The initiation of a study of these proportions and structure marks a major milestone in the advancement of peripheral artery disease therapy in general and provides further proof of a company committed to invest in clinical research that generates the data physicians need to be confident that their patients are receiving the best care.”

The Medtronic IN.PACT Global SFA clinical study is part of the company's global IN.PACT clinical program that will include 24 studies involving approximately 4,000 patients and 200 sites across more than 80 countries worldwide to thoroughly investigate DEBs for the treatment of arterial disease in coronary and peripheral vessel beds.

As reported on March 20 in Endovascular Today, 12-month results from a multicenter Italian registry evaluating the use of the In.Pact Admiral DEB were published by Antonio Micari, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2012;5:331–338). The company noted that this was the first study of its kind to measure quality of life improvements when using a DEB to treat patients with peripheral artery disease.

The device showed an 83.7% primary patency rate and a 7.6% target lesion revascularization rate. Additionally, the trial resulted in statistically significant quality of life improvements across multiple endpoints, including walking distance and shift in Rutherford classification.

Medtronic advised that the In.Pact DEBs received CE Mark approval in 2008 and 2009 and are available in many countries around the world. In.Pact DEBs are not commercially available in the United States. The In.Pact Admiral DEB balloon is limited to use under an investigational device exemption (IDE) granted by the US Food and Drug Administration and is currently being studied in the Medtronic IN.PACT SFA II clinical study.