Tenaxis Medical receives FDA approval for its ArterX surgical sealant


On 4 March 2013, Tenaxis Medical, 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 commercialisation 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 hospitalisation 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 haemostasis 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 haemostasis in a wide variety of surgical procedures,” said William Cohn, director, Minimally Invasive Surgical Technology at Texas Heart Institute in Houston, USA, and a Tenaxis Board Member.

“This is the outcome of an extensive and rigorous development and testing process,” says Ronald Dieck, president, chief executive officer, director, and one of the founders of Tenaxis. “We take pride in the fact that we have been able to listen to the surgeon’s concerns and ArterX is a product of this process. It is always gratifying to develop an innovative product that gives the surgeon a better tool, thus greatly benefitting the patient.”

“ArterX is simple to use and extremely effective in controlling suture line bleeding from vascular anastomoses,” explains Larry Scher, Montefiore Hospital in New York, who participated in the US pivotal clinical trial. “Application of ArterX to anastomosis between arteries and prosthetic grafts or patches in procedures such as carotid endarterectomy, lower extremity bypass procedures, and arterio-venous grafts reduced suture line bleeding and operating time significantly.”