Abbott's Supera stent gains FDA approval for peripheral artery disease

Abbott announced Friday that the FDA cleared its Supera peripheral stent system to treat blockages caused by peripheral artery disease (PAD) in the superficial femoral and proximal popliteal arteries. Chuck Foltz, senior vice president of the company's vascular division, noted that the decision "gives Abbott rapid entry into one of the fastest-growing segments of the peripheral stent market."

The approval was supported by data from the SUPERB trial, which demonstrated that the Supera stent was "highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases," Abbott said. Results also showed that there were no stent fractures in the first year after treatment, and a "very low" stent fracture rate of 0.5 percent at two years. Principal investigator Kenneth Rosenfield said the findings indicate the product "is very effective in easing leg pain, enabling the majority of patients to resume their activities."

The Supera stent, which Abbott gained through its August 2013 acquisition of IDEV Technologies, also has CE-mark approval for treating blocked blood vessels caused by PAD.