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news.Company to begin US clinical trial at up to 10 clinical sites with 50 patients
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Flexible Stenting Solutions (FSS) has received Conditional Investigational Device Exemption (IDE) approval for its FlexStent Femoropopliteal Self Expanding Stent System. FSS is now authorized to begin its US clinical trial at up to 10 clinical sites and 50 patients. FSS expects to address FDA conditions within the next 45 days.
FSS believes that the femoropopliteal stent and delivery system can improve patient care in the high growth peripheral vascular segment. The FlexStent provides an atraumatic, fatigue resistant stent. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist.
Janet Burpee, CEO of FSS, said: “We believe our device could provide the physicians a viable solution for treatment of long, difficult, and diffuse lesions in the femoropopliteal arteries. We are happy to have the opportunity to work with Mr. Gray, and needless to say are very excited about receiving this conditional IDE approval from the FDA.”
The company has previously announced that it has received FDA 510(k) clearance for the Biliary FlexStent system, and CE Mark authorisation for the Biliary and Femoropopliteal FlexStent systems.