Transluminal's Velox CD Vascular Closure Device Approved in Europe

July 30, 2014—Transluminal Technologies LLC announced European CE Mark approval for the Velox CD vascular closure device, which provides a safe and predictable means for achieving immediate hemostasis after percutaneous femoral procedures. The Velox CD is indicated for closing arteriotomies ranging in size from 5 F to 8 F.

Transluminal Technologies advised that CE Mark approval was granted on the strength of a pivotal clinical trial that demonstrated the safety and effectiveness of the device in fully anticoagulated patients.

In the company’s press release, Shing-Chiu Wong, MD, a leading clinical participant in the Velox CD clinical studies, commented, “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.” Dr. Wong is Director of Cardiac Catheterization Laboratories at the New York Presbyterian–Weill Cornell Medical Center in New York, New York.

According to the company, Velox CD is an easy-to-use, single-use instrument to deliver an implant to the vessel wall. The device avoids the need for time-consuming manual compression and allows for shorter patient time to ambulation. The implant is made from an magnesium alloy, which was designed by the company to bioabsorb rapidly after implantation. The implant's intraluminal portion dissolves within 24 hours, while the remainder is completely resorbed within 2 weeks.