Abbott Park, Ill.-based Abbott said the stent is designed to conform to the shape of patients’ blood vessels. The FDA approved the Supera device for treating occlusions in the superficial femoral artery and the proximal popliteal artery.
"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," Dr. Kenneth Rosenfield of the Massachusetts General Hospital, principal investigator of the Superb clinical trial, said in prepared remarks. "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."
"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," added vascular senior vice president Chuck Foltz. "FDA approval of the Supera stent gives Abbott rapid entry into 1 of the fastest-growing segments of the peripheral stent market, providing Abbott with 1 of the most comprehensive and competitive peripheral technology portfolios in the industry."
Abbott acquired the Supera device when it bought IDEV Technologies for $310 million last year.