Abbott Vascular has received approval from the US Food and Drug Administration (FDA) for its Supera peripheral stent system, designed for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease.
Specifically, the FDA has approved the Supera peripheral stent system for treating blockages in the superficial femoral artery and the proximal popliteal artery.
According to the company, the Supera stent mimics rather than resists the natural movement of leg arteries using interwoven wire technology to restore blood flow to the treated area, while offering strength and flexibility for resistance to fractures and kinks.
The clinical results from the SUPERB trial were used to support the FDA approval of the Supera peripheral stent system.
The Supera system is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery and/or proximal popliteal artery with a reference vessel diameter of 4.0-6.5mm, and lesion lengths up to 140mm.
Abbott vascular senior vice president Chuck Foltz noted the 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," Foltz added.