Medtronic Drug-Coated Balloon Receives FDA Approval for Treating Peripheral Artery Disease in Upper Leg

MINNEAPOLIS --  Medtronic, Inc. announced today that the U.S. Food and Drug Administration (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.

"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."

The DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularization (CD-TLR) rate ever reported for an interventional treatment of PAD in the superficial femoral artery (SFA), with only 2.4 percent of patients treated with the IN.PACT Admiral DCB requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty (PTA).

The data also revealed the highest reported rates of primary patency, which measures sustained restoration of adequate blood flow through the treated segment of the artery. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8 percent sustained restoration of blood flow in the DCB group compared to 66.8 percent for the PTA group. Using the trial's protocol definition, primary patency assessed at 12 months of follow up was 82.2 percent for the DCB group and 52.4 percent for the PTA group.

The exceptionally positive clinical data from the pivotal IN.PACT SFA Trial, which compared treatment with the IN.PACT Admiral DCB to standard balloon angioplasty, has been approved by the FDA without the use of an independent advisory panel.

By reducing the need for repeat procedures, the new device is also proving to be economically attractive. Results from an interim economic analysis of the IN.PACT SFA Trial revealed that treatment with the IN.PACT Admiral DCB is cost-effective compared to balloon angioplasty from discharge through one-year of follow-up, indicating the potential to lower overall healthcare costs over the longer term.

"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."

The IN.PACT Admiral DCB received the CE (Conformité Européene) mark in 2009 and has been widely adopted by European physicians, leading the market with nearly 100,000 patients treated.

Source: Medtronic, Inc.