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.

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.


The IN.PACT Admiral DCB received the CE (Conformité[<00E9>][<00E9>] Européene) mark in 2009 and has been widely adopted by European physicians, leading the market with nearly 100,000 patients treated.

Defined as atherosclerosis (hardening of the arteries) outside the heart and brain, peripheral arterial disease (PAD) affects an estimated 8-12 million people in the U.S.1 The condition is caused by the build-up of plaque in the arteries that carry oxygenated blood from the heart to the rest of the body. The plaque can harden over time, narrowing the arteries and restricting blood flow. Complications related to PAD are heightened due to common co-morbidities: 63 percent of people with PAD also have coronary artery disease, and one in three people with diabetes over age 50 are also living with PAD.2,3,4

PAD most commonly affects arteries in the legs, and when present in the upper leg, greatly increases risk of a sudden heart attack or stroke.5 Blocked blood supply to the muscles and tissues in the legs can cause recurrent and painful muscle cramping in the thigh and/or upper calf while walking or climbing stairs that can be restrictive and impair quality of life. Experiencing pain, even while at rest or while sleeping, is a sign of a more severe disease. Without proper treatment, 30 percent of people with PAD are likely to die within five years from a PAD-related heart attack or stroke.3

In collaboration with leading clinicians, researchers, and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular diseases and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

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