Flexible Stenting Solutions, Inc. Receives Conditional IDE Approval for FlexStent[R] Femoropopliteal Self Expanding Stent System.EATONTOWN, N.J. -- Flexible Stenting Solutions Inc. ("FSS FSS Federal Supply Service (US General Services Administration) FSS Flight Service Station FSS Family Self-Sufficiency FSS Fixed Satellite Service FSS Forensic Science Service (Great Britain) "), a leading developer of next generation peripheral arterial and biliary stents, announced today that it has received Conditional Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) approval for its FlexStent([R]) Femoropopliteal Self Expanding Stent System. With this approval, FSS is initially authorized to begin its US clinical trial at up to 10 clinical sites and 50 patients. FSS expects to address FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. conditions within the next 45 days. The US clinical trial will be led by Principle Investigator Dr. William Gray. Dr. Gray is the Director of Endovascular Intervention at NY Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy. He will be presenting FSS's interim OUS six month clinical data at VIVA in Las Vegas, NV next month. FSS believes that this next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment. The fully connected flexible FlexStent([R])provides an atraumatic atraumatic /atrau·mat·ic/ (a?traw-mat´ik) not producing injury or damage. atraumatic not producing injury or damage. atraumatic adjective Without injury , highly durable, fatigue resistant stent. Ithas superior radial stiffness, as well as excellent conformability con·form·a·ble adj. 1. Corresponding; similar: plans that are conformable to your wishes. 2. Quick to comply; submissive. 3. to and mobility with the treated vessel. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist. Janet Burpee
The burpee is a calisthenic exercise performed to increase strength and explosiveness. , FSS's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. commented, "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 Dr. Gray, and needless to say are very excited about receiving this conditional IDE approval from the FDA." The company previously announced that it has received FDA 510(k) clearance for the Biliary FlexStent([R]) system, and CE Mark authorization for the Biliary and Femoropopliteal FlexStent([R]) systems. About Flexible Stenting Solutions Inc. Flexible Stenting Solutions Inc. (FSS) is a leading developer of third-generation flexible peripheral arterial 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 staged launch of products will provide clinical solutions throughout the body. FSS is an ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485:2003 certified company and has received regulatory approvals on several products. For more information, visit the company's website at www.flexiblestent.com. FlexStent([R])is a registered trademark of Flexible Stenting Solutions, Inc. |
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