Transluminal Technologies receives CE Mark approval for velox CD vascular closure device
SYRACUSE, N.Y., July 30, 2014 /PRNewswire-iReach/ -- Transluminal Technologies LLC, a Syracuse, NY-based medical device company, has announced today that they have received CE Mark approval for the velox CD™ Vascular Closure Device. Velox CD™ provides a safe and predictable means for achieving immediate hemostasis following percutaneous femoral procedures. The single size velox CD™ is indicated for closing arteriotomies broadly ranging in size from 5F to 8F.
Velox CD™ utilizes patented mechanisms to provide an easy-to-use single-use instrument to deliver an implant to the vessel wall, thereby avoiding the need for time-consuming manual compression and allowing for shorter patient time-to-ambulation. The implant is wholly made from a proprietary magnesium alloy designed to bioabsorb rapidly after implantation. The implant's intraluminal portion dissolves within 24 hours, while the remainder is completely resorbed within two weeks.
CE Mark approval has been granted on the strength of a pivotal clinical trial in which the safety and effectiveness of the device in fully anti-coagulated patients was demonstrated.
Dr. Shing-Chiu Wong, Director of Cardiac Catheterization laboratories at the New York Presbyterian -- Weill Cornell Medical Center and a leading clinical participant in the velox CD™ clinical studies states, "Velox CD™ is the world's first metal-based bioabsorbable closure device that is simple to use and highly predictable for femoral access site hemostasis. This innovation should prove to be a significant enhancement to the existing offerings."
"Velox CD™ is a true next generation vascular closure device that addresses the shortcomings of extant products with vastly improved implant delivery and bioabsorption technologies," said Co-Founder and President Stephen Green. "Transluminal will continue its commitment to innovation in interventional devices and improved patient outcomes."
About Transluminal Technologies
Transluminal Technologies LLC is a privately held company established in 2007 to design, develop, and commercialize new technologies and techniques to close arteriotomies following percutaneous procedures. The company has focused efforts on absorbable biometals with residence time appropriate to the healing continuum for a given application.
Media Contact: Stephen Green, Transluminal Technologies, LLC, 315-476-7510, email@example.com
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SOURCE Transluminal Technologies, LLC