FDA Approves Abbott Supera Stent For PAD

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved its Supera Peripheral Stent System for the treatment of patients with blocked blood vessels in the upper leg due to peripheral artery disease (PAD).

Peripheral artery disease takes place when fat and cholesterol buildup causes arteries outside the heart to narrow. This reduces blood flow to different parts of the body, typically in the legs. The disease causes leg pain aside from increased risk of heart attack and stroke. PAD affects around 12 to 20 percent of patients 65 years old and above in the U.S.

“Doctors are increasingly identifying peripheral artery disease as a major cause of leg pain, which can limit people’s ability to live a healthy lifestyle. Treatment with the Supera stent, as shown by the results of the SUPERB study, is very effective in easing leg pain, enabling the majority of patients to resume their activities,” said Kenneth Rosenfield, M.D., section head of Vascular Medicine and Intervention at Massachusetts General Hospital and the principal investigator of the SUPERB clinical trial assessing the Supera stent.

Supera mimics the arteries’ natural movement to help ease leg pain in walking. The proprietary interwoven wire technology restores blood flow to the affected areas. The FDA approved Supera stent to treat blockages in the superficial femoral artery (SFA), a blood vessel located in the thigh, and the proximal popliteal artery (PPA), a blood vessel located above the knee. The approval was supported by data from the SUPERB clinical trial, where the Supera stent demonstrated efficacy in opening up blocked blood vessels in the upper leg.

Chuck Foltz, SVP of vascular at Abbott, said “FDA approval of the Supera stent provides an additional treatment option that can make a positive impact on the lives of people suffering from peripheral artery disease. FDA approval of the Supera stent gives Abbott rapid entry into one of the fastest-growing segments of the peripheral stent market, providing Abbott with one of the most comprehensive and competitive peripheral technology portfolios in the industry.”

The company expanded its product portfolio with the addition of the Supera stent through the acquisition of IDEV Technologies in August 2013.