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.
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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.
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By GlobalDataAccording 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."
