Medtronic announced Friday that it had launched a U.S. clinical study of drug-coated balloons to test them on patients with peripheral artery disease affecting the lower extremity.
No drug-coated balloons are currently approved outside of clinical trials, said Joe McGrath, a Medtronic spokesman. Roughly 8 to 12 million people are affected with peripheral artery disease, according to the American College of Cardiology, and one form of the disease causes ischemic leg pain and immobility, critical limb ischemia and amputations.
Medtronic’sIN.PACT SFA II study will evaluate the safety and effectiveness of the company’s IN.PACT Admiral drug-eluting balloon in treating peripheral artery disease in the superficial femoral arteryin the heart and/or proximal popliteal arteryin the knee area.
The first patients enrolled in the study were treated earlier this week at Washington Hospital in Fremont, California and at St. Vincent Hospital in Indianapolis.
The competing products to Medtronic’sIN.PACT Admiral drug-eluting balloon are developed by B. Braun and Lutonix, which was acquired by C.R. Bard in December 2011.