Transluminal Technologies, a US-based medical device company, has secured CE Mark approval for its velox CD vascular closure device.
Velox CD is said to offer a safe and predictable means for achieving immediate hemostasis following percutaneous femoral procedures.
The CE Mark approval is based on data from a pivotal clinical trial which assessed the safety and effectiveness of the device in anti-coagulated patients.
The company said that the single size velox CD can close arteriotomies ranging from 5F to 8F.
The bio-absorbable closure device uses patented mechanisms to provide a single-use instrument for delivering an implant to the vessel wall, helping avoid manual compression and allowing for shorter patient time-to-ambulation.
Velox CD is made of a magnesium alloy designed to bioabsorb rapidly after implantation.
According to the company, the implant’s intraluminal portion dissolves within 24 hours, while the remainder is completely absorbed within two weeks.
Dr. Shing-Chiu Wong, New York Presbyterian Weill Cornell Medical Center director of cardiac catheterization laboratories and a clinical participant in the velox CD clinical studies, said: "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."
Transluminal Technologies co-founder and president Stephen Green said: "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."