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Flexible Stenting Solutions
23 Christopher Way suite 103
Eatontown, NJ 07724 USA
phone:732-578-0060
fax:732-578-0068
Symbol Private
Founded 2006
Employees 11
www.flexiblestent.com
Research Sector
Summary Description
Development and commercialization of flexible, durable self expanding stents
Management
Janet Burpee, CEO, formerly Cofounder and CEO of Burpee Materials. Ms. Burpee has been designing stents since 1993, which pre-dates the US launch of the first stent by Cordis/JNJ, and is well-known among industry executives for her expertise. She has largely contributed to the designs of the Genesis, Velocity and Cypher stents, marketed by Cordis/JNJ [NYSE: JNJ], as well as stents and nitinol-related processes for Guidant, Cook and Boston Scientific [NYSE: BSX]. Prior to co-founding Burpee Materials in 1998, she served in positions of increasing responsibility for IsoStent [acquired by Cordis/JNJ; ultimately JNJ’s BX stent platform], Nitinol Devices and Components [acquired by Cordis/JNJ; ultimately JNJ’s SX stent platform], Advanced Surgical, and Advanced Cardiovascular Systems [later Guidant]. She is the named co-inventor or developer of numerous medical devices and fabrication processes, including FSS proprietary technology. Brad Beach, VP Research and Development, formerly Development Manager for Burpee Materials. Prior to joining Burpee Materials, Mr. Beach was Director of Engineering for MecTech, Inc. Previously, he acted as an independent consultant for firms such as Novellus Systems [NASDAQ; NVLS], Tektronix, Electrolux Home Products, Consolidated Metco, and Siemens Corporation [NYSE: SI]. Mr. Beach began his career in engineering-focused positions of increasing responsibility for Tektronix, Sparton Electronics [NYSE: SPA], Pitney Bowes [NYSE: PBI], Lockheed Martin Fairchild Systems [NYSE: LMT], and the Aerospace Systems Division of Harris Corporation [NYSE: HRS]. Joseph Griffin, VP QA/RA/CA, brings over 25 years of experience in the design, development, manufacture, clinical trial, and regulatory compliance of both disposable and implantable cardiovascular and vascular devices. Mr. Griffin was previously Founder, CEO and President of Professional Catheter Corporation, the predecessor to ProCath Corporation, as named upon acquisition by EP MedSystems, now St. Jude Medical [NYSE: STJ]. Previously, Mr. Griffin was Research and Development Manager and Temporary Pacing Lead Manufacturing Manager for Oscor Medical Corporation; Director of R&D and Technical Services for Nova Medical Specialties, a Division of B. Braun America; and Design Drafter for American Catheter Corporation, a subsidiary of Johnson and Johnson [NYSE: JNJ]. He is the inventor and co-inventor of 15 medical device related U.S. Patents.
Keywords
privately held, medical device, company, third generation, self-expanding, stent, superficial femoral, popliteal arteries

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Updated: Jul. 09, 2010

Description
Flexible Stenting Solutions is a privately held medical device company focused on the development and commercialization of flexible stents built on a proprietary design platform. The company has developed a third generation self-expanding stent designed for the harsh loading conditions present in the superficial femoral and popliteal arteries.
Products / Services
A Self-Expanding Peripheral Stenting System - an innovative fully connected, flexible, strong and durable nitinol stent delivered from a straightforward and accurate stent delivery system. CE Mark authorization was received in January 2009 for the FlexStent® Femoropopliteal Self Expanding (SE) Stent Sytem. The FlexStent® Biliary Self Expanding Stent System also received CE Mark authorization in January 2009 and 510(k) clearance in September 2009. The FSS platform offers a nearly fully-connected, very strong yet flexible stent, engineered to solve the problems of first and second generation flexible stents.
Technology / Differentiation
Flexible Stenting Solutions’ lead product candidate is a self-expanding stent specifically designed for the harsh loading conditions present in the superficial femoral (SFA) and popliteal (POP) arteries, which are the dominant sites of peripheral vascular disease in the lower extremity. While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting has been previously limited by inadequate stent design. Unlike the heart, where current coronary stent design has been optimized, the arteries of the leg are tortuous and are routinely bent, stretched and twisted. Stents currently used in lower extremities have unacceptably high rates of breakage, vessel damage and restenosis (blockage of the artery). The design of the FSS flexible stent is fully interconnected to prevent “fish scaling,” which is common with prior generation non-interconnected stents. The FSS stent leverages state of the art technology the integration of helically wound struts with helical flexible coils providing a mechanism optimized for vigorous applications, while allowing ease of use and placement for the vascular physician. Our stent offers the following advantages over currently available stents:
Status
CE Mark authorization was received in January 2009 for the FlexStent® Femoropopliteal Self Expanding (SE) Stent Sytem. The FlexStent® Biliary Self Expanding Stent System also received CE Mark authorization in January 2009 and 510(k) clearance in September 2009. The FSS platform offers a nearly fully-connected, very strong yet flexible stent, engineered to solve the problems of first and second generation flexible stents.