FDA Approves Medtronic Drug-Coated Balloon for Peripheral Artery Disease in Upper Leg

Medtronic has gained U.S. FDA approval for its IN.PACT Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the upper leg.


It was back in June 2013 that we last commented on Medtronic’sĀ IN.PACT Admiral DCB, which at the time had seen full enrollment in studies that were intended to underpin market approval. Sure enough, eighteen months on, the company is claiming that those studiesĀ demonstrated the best clinical outcomes ever reported for peripheral artery disease in the upper leg. The device has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies.

The IN.PACT Admiral DCB is designed to reopen specifically the superficial femoral and popliteal arteries, when they have been narrowed or blocked by plaque. Once deployed in the artery, the balloon delivers a proven, safe and effective 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.

Investigator comments

“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,” according to Dr. Michael R. Jaff, Paul and Phyllis Fireman Chair in Vascular Medicine at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston, Mass., who 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.”

Company comments

“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 U.S.,” 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.”

Source: Medtronic, Inc.

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