Healthcare Industry News: Biliary Stent
News Release - February 2, 2011
FSS Receives Full Investigational Device Exemption (IDE) Approval for its FlexStent(R) Stent SystemEATONTOWN, N.J.--(Healthcare Sales & Marketing Network)-- Flexible Stenting Solutions, Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and Biliary Stents, announced today that it has received full FDA Investigational Device Exemption (IDE) approval for its FlexStent® Femoropopliteal Self Expanding Stent System. With this approval, FSS is authorized to begin full enrollment for the OPEN Trial (US Evaluation of Safety and Efficacy of the FlexStent® Femoro-pOPliteal Self-Expanding StENt System).
FSS believes that this next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment. The FlexStent® provides an atraumatic, highly durable, fatigue resistant stent. FSS focused on physician requests for a flexible, durable, conformable and easy-to-deliver stent. “The primary goal of a stent is to atraumatically keep a vessel open,” stated Janet Burpee, FSS’s CEO and co-inventor of the FlexStent technology. “The high radial strength, and equally important, the unique construction and accurate deliverability offers a stenting solution which maximizes scaffolding for the vessel while allowing the vessel to naturally move with the bodies motion."
The company previously announced that it has received FDA 510(k) clearance for the biliary FlexStent® system, and CE Mark authorization for the Biliary and Femoropopliteal FlexStent® systems which includes the same enhanced stent delivery system to be used in the US clinical study.
About Flexible Stenting Solutions Inc.
Flexible Stenting Solutions Inc. (FSS) is a leading developer of third-generation flexible peripheral arterial, venous, neurovascular and Biliary Stents. Its fully connected stent has coupled technology with clinical needs by providing an atraumatic, highly durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability. FSS is an ISO 13485:2003 certified company and has received regulatory approvals on several products.
For further information on Flexible Stenting Solutions, please visit the company website at www.flexiblestent.com.
FlexStent® is a registered trademark of Flexible Stenting Solutions, Inc.
Source: Flexible Stenting Solutions
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