Tenaxis Medical, a Mountain View, CA-based medical device company, has received expanded CE Mark approval for its ArterX Surgical Sealant. The ArterX is a two-part liquid system that when mixed together and applied to the vasculature will transform into a flexible gel in less than 15 seconds, achieving hemostasis by mechanically sealing areas of leakage. Results of a pivotal clinical study of ArterX were published late last year in the Annals of Vascular Surgery and demonstrated that ArterX delivered markedly higher efficacy versus the control. The reported reduction in surgical and hospitalization time suggests that the product offers significant advantages to patients and clinicians, as well as economic advantages to the healthcare system.
ArterX is rather simple to use and extremely effective in controlling suture line bleeding from vascular anastomoses. ArterX represents a major advancement in sealant technology because of its ability to provide pristine hemostasis in a wide variety of surgical procedures. The intended use for the product in Europe has now been expanded to cardiac, vascular and soft tissue reconstructions. The product can now be used in a wide variety of surgical procedures including the vasculature and major organs that involve bleeding or leakage.
In addition to ArterX Surgical Sealant, Tenaxis is also developing a second high-performance sealant, Prevent GI Sealant, for use throughout the intestinal tract.