Medtronic ($MDT) has had a busy week already with its announcements about product development. And that trend continues today as it revealed that it will soon start a study of its IN.PACT Admiral drug-eluting balloon for patients with atherosclerotic disease in the superficial femoral or popliteal arteries.
The company plans to enroll roughly 1,500 real-world patients at up to 80 sites around the world. The study results will not only "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," according to Dr. Gunnar Tepe, chief of radiology at Klinikum Rosenheim in Germany and chairman of the IN.PACT Global SFA steering committee.
The Journal of the American College of Cardiology recently published results of a registry evaluating the IN.PACT Admiral drug-eluting balloon in the superficial femoral artery. Data showed that use of the drug-eluting balloon in 105 patients at 12 months resulted in an 83.7% primary patency rate and a target lesion revascularization rate of 7.6%. According to the American College of Cardiology, roughly 8 million to 12 million patients are affected with peripheral artery disease, MedCity News notes.
Last week, Medtronic announced that it had launched the U.S. study of Admiral, reporting patient enrollment in California and Indiana. The Medtronic IN.PACT drug-eluting balloons have the CE mark, but the FDA has yet to sign off on Admiral. As MedCity News notes, Medtronic does have competition in this area from B. Braun and Lutonix.
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