FDA approves IN.PACT DCB for treatment of Peripheral Artery Disease- Medtronic

Medtronic, Inc. announced that the FDA has approved the company's IN.PACT Admiral drug-coated balloon (DCB) for the interventional treatment of Peripheral Artery Disease (PAD) in the upper leg, 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 IN.PACT Admiral DCB offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported for this disease state and 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 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 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.