FDA approves Abbott’s Supera peripheral stent system

30 March 2014 (Last Updated March 30th, 2014 18:30)

Abbott Vascular has obtained approval from US Food and Drug Administration (FDA) for its Supera peripheral stent system, intended for treating patients with blocked blood vessels in the upper leg caused by peripheral artery disease.

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Abbott Vascular has obtained approval from US Food and Drug Administration (FDA) for its Supera peripheral stent system, intended for treating patients with blocked blood vessels in the upper leg caused by peripheral artery disease.

The FDA has approved the Supera peripheral stent system specifically for treating blockages in the superficial femoral artery and the proximal popliteal artery.

The Supera peripheral stent 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 4.0mm-6.5mm, and lesion lengths up to 140mm.

The device mimics rather than resists the artery's natural movement. It helps the patients with peripheral artery disease to ease their leg pain while walking.

Incorporating proprietary interwoven wire technology, the Supera stent system restores blood flow to the treated area.

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

Results from the SUPERB clinical trial results were used to support FDA approval of the Supera peripheral stent system.

The SUPERB clinical trial results demonstrated that the Supera system is 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.

"The device mimics rather than resists the artery's natural movement. It helps the patients with peripheral artery disease to ease their leg pain while walking."

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%.

Abbott vascular senior vice president Chuck Foltz said 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 said.

Abbott has expanded its peripheral technology portfolio of guidewires, balloon dilatation catheters and stents with the addition of Supera stent through the acquisition of IDEV Technologies in August 2013.

IDEV Technologies' self-expanding nitinol stent system Supera Veritas has CE Mark approval in Europe for treating blockages in blood vessels due to peripheral artery disease.


Image: Supera peripheral stent system for treatment of peripheral artery disease. Photo: courtesy of IDEV Technologies.