FDA Approves Medtronic Drug-Coated Balloon for Peripheral Artery Disease

Minneapolis, Minn.-based Medtronic Inc., currently poised to complete the landmark acquisition of Covidien plc, has received U.S. Food and Drug Administration (FDA) approval for its In.Pact Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the upper leg. PAD is a serious and common cardiovascular condition that causes pain in the legs and is known to be associated with a four- to five-fold increase in risk for heart attack and stroke.

The device is designed to reopen arteries located in the upper leg, specifically the superficial femoral and popliteal arteries, when they have been narrowed or blocked by plaque. Once deployed in the artery, the balloon delivers dose of the anti-restenotic drug paclitaxel to the artery walls. The drug aims to prevent the artery from narrowing again by minimizing scar tissue formation.

“The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease in the leg,” said Dr. Michael R. Jaff, D.O., Paul and Phyllis Fireman Chair in Vascular Medicine at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston, Mass. He participated in the studies that led to the new device’s FDA approval as the medical director of VasCore, the Vascular Ultrasound Core Laboratory. “Data from clinical trials evaluating this new drug-coated balloon have consistently demonstrated improved patient outcomes.”

Trial data showed 2.4 percent of patients treated with the In.Pact Admiral DCB requiring a repeat procedure at one year, compared to 20.6 percent treated with percutaneous transluminal angioplasty, an alternative to DCB.

“Having shown success in Europe for several years, we are excited to bring the In.Pact Admiral drug-coated balloon to patients and physicians in the United States,” said Tony Semedo, senior vice president and president of Medtronic’s aortic and peripheral vascular business. “In addition to being a key growth driver, the In.Pact Admiral DCB delivers on our commitment to providing innovative technologies that not only provide clinical benefit, but also economic value.”

The device received the CE mark in 2009 and has been in use in Europe since then.