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February 1, 2011
FSS Receives IDE Approval for Femoropopliteal Study of FlexStent
February 2, 2011—Flexible Stenting Solutions, Inc. (FSS, Eatontown, NJ) announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for its FlexStent femoropopliteal self-expanding stent system.
The IDE allows FSS to begin enrollment for the OPEN trial, a prospective, single-arm trial enrolling up to 227 patients at up to 40 clinical sites in the United States. The study is scheduled to begin in the first quarter of 2011. William A. Gray, MD, is principal investigator of OPEN.
Dr. Gray commented, “This is a major milestone for the company and in combination with compelling early overseas data affords it the opportunity to further demonstrate the safety and efficacy of the product and ultimately lead to premarket approval here in the United States.”
According to the company, the device is an atraumatic, highly durable, fatigue resistant stent with high radial strength. FSS previously announced that it has received FDA 510(k) clearance for the biliary FlexStent system. In Europe, CE Mark approval has been granted for the biliary and femoropopliteal FlexStent systems, which include the same stent delivery system to be used in the United States clinical study.
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