FDA approves Supera stent

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Abbott announced that its Supera peripheral stent system has received US Food and Drug Administration (FDA) approval to treat patients with blocked blood vessels in the upper leg caused by peripheral artery disease.

According to a company release, the Supera stent, which mimics rather than resists the artery’s natural movement, is an important advancement for many peripheral artery disease patients, helping to ease their leg pain while walking. Its unique, proprietary interwoven wire technology restores blood flow to the treated area, while offering strength and flexibility. Specifically, the Supera stent is now approved to treat blockages in the superficial femoral artery and the proximal popliteal artery.

Compared to other nitinol stents used to treat blocked blood vessels in the upper leg, the Supera stent is more flexible, stronger and resistant to kinks or fracture under vigorous movement.


“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,” says Kenneth Rosenfield, section head of Vascular Medicine and Intervention at Massachusetts General Hospital and the principal investigator of the SUPERB clinical trial, which evaluated the Supera stent. “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.”   

 


Data from the SUPERB clinical trial, which was used to support FDA approval of the Supera stent, have shown the Supera stent to be highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases, and results have been shown to last over time. In addition, during the first year after treatment with the Supera stent there were no stent fractures, and at two years there was a very low stent fracture rate of 0.5%.

 


The Supera stent has CE mark in Europe for treating blocked blood vessels caused by peripheral artery disease.

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