Transluminal Technologies LLC, a Syracuse, New York-based medical device company, has received CE Mark approval for the velox CD Vascular Closure Device.
Velox CD provides a safe and predictable means for achieving immediate haemostasis following percutaneous femoral procedures. The single size velox CD is indicated for closing arteriotomies broadly ranging in size from 5F to 8F.
Velox CD utilises 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 Catheterisation 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."