Tenaxis Medical, Inc., (www.tenaxismedical.com), a medical device company focused on the development of functionally designed surgical sealants has received FDA approval to bring its innovative ArterX Surgical Sealant to the market.
The company plans to start commercialization of ArterX in the United States early in 2013.
ArterX is the first product developed by Tenaxis and is specifically designed for use in vasculature reconstruction in a wide variety of surgical procedures. Results of the pivotal clinical study of ArterX were recently published 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 may offer economic advantages to the healthcare system.
ArterX Surgical Sealant is a two-part liquid system that when simultaneously mixed and applied to the vasculature will transform into a flexible gel in less than 15 seconds. The product achieves hemostasis by mechanically sealing areas of leakage. ArterX is approved for prophylactic use as well as treating bleeding after clamp release.
"ArterX represents a major advancement in sealant technology because of its ability to provide pristine hemostasis in a wide variety of surgical procedures," said William Cohn , MD, Director, Minimally Invasive Surgical Technology at Texas Heart Institute in Houston and a Tenaxis Board Member.