Healthcare Industry News:  peripheral artery disease 

Devices Interventional FDA

 News Release - March 17, 2009

Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent(R) Femoropopliteal Self Expanding Stent System

EATONTOWN, N.J.--(HSMN NewsFeed)--Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial stents has submitted an Investigational Device Exemption (IDE) application to the FDA for its FlexStent(R) Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries. This next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment.

While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate stent design. The fully connected flexible FlexStent(R) has coupled technology with clinical needs by providing a highly durable and fatigue resistant stent. The FlexStent(R) has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist.

FSS’s principle investigator for the US clinical trial will be Dr. William Gray, the Director of Endovascular Intervention at NY Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy. Dr. Gray commented, “The unique design developed for the FlexStent(R) intends to address the important issue of stent fracture in the demanding femeropopliteal arterial segment, while maintaining radial force. I am looking forward to beginning the clinical trial and excited to be part of this endeavor.”

FSS’ primary focus is patient care. peripheral artery disease in the femoropopliteal arteries typically presents long, difficult, and diffuse lesions at and above the knee. “We believe the FlexStent(R) represents a true third generation femoropopliteal stent and delivery system that can significantly improve clinical outcomes in this hard to treat area,” said Janet Burpee, CEO of Flexible Stenting Solutions, Inc. “We are delighted to have had and continue to have the opportunity to work with a world-class scientific advisory board who helped us get to this important milestone. The addition of Dr. Gray as our US principle investigator promises a successful and expeditious US clinical trial.”

About Flexible Stenting Solutions Inc.

Flexible Stenting Solutions Inc. is a leading developer of third generation flexible peripheral arterial and biliary stents. The Company’s lead vascular product candidate is a self-expanding stent specifically designed for the harsh loading conditions present in the dominant sites of peripheral vascular disease in the lower extremity. The FlexStent(R) leverages state of the art technology while allowing ease of use and placement for the physician. For more information about Flexible Stenting Solutions please visit the company’s website at www.flexiblestent.com.


Source: Flexible Stenting Solutions

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