The US Food and Drug Administration (FDA) has approved Tenaxis Medical's ArterX Surgical Sealant, designed for use in vasculature reconstruction in various surgical procedures.
ArterX Surgical Sealant is a two-part liquid system that will transform into a flexible gel, when simultaneously mixed and applied to the vasculature, in less than 15 seconds
In addition, ArterX is approved for treating bleeding after clamp release, claims the company.
During the company's pivotal clinical study, ArterX delivered markedly higher efficacy versus the control and reduced surgical and hospitalization time, which suggests that the product may offer economic advantages to the healthcare system.
Montefiore Hospital cardiovascular and thoracic surgery clinician Larry Scher said ArterX is simple to use and effective in controlling suture line bleeding from vascular anastomoses.
"Application of ArterX to anastomosis between arteries and prosthetic grafts or patches in procedures such as carotid endarterectomy, lower extremity bypass procedures and AV grafts reduced suture line bleeding and operating time significantly," Scher added.
The company is planning to begin US marketing of ArterX in the early 2013.
