FDA approves Supera Peripheral Stent System

Abbott Vascular today announced that the FDA has approved its Supera Peripheral Stent System to treat blocked blood vessels in the upper leg due to peripheral arterial disease.

The stent is indicated to improve luminal diameter of the superficial femoral artery and proximal popliteal artery for lesion lengths up to 140 mm. Its interwoven wire design allows for flexibility and strength to support vigorous movement, according to a press release.

The approval was based in part on results of the SUPERB trial, which demonstrated the efficacy and durability of the stent in patients with PAD. Study results indicated there were no cases of stent fracture after the first year of treatment. After 2 years, the rate of stent fracture was 0.5%, according to the press release.

"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," Kenneth Rosenfield, MD, section head of vascular medicine and intervention at Massachusetts General Hospital and the principal investigator of the SUPERB clinical trial, said in the press release. "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."

The Supera stent has previously received a CE mark approval in Europe for the treatment of blood vessels blocked due to PAD.