Tenaxis Medical, a developer of high-performance sealants, has received approval to expand its CE Mark indications for ArterX surgical sealant, from its EU notified body, BSI.
ArterX Surgical Sealant is specifically designed to be applied directly over suture or staple line to seal the area to stop and prevent leaks, thereby achieving hemostasis during surgery.
The sealant has now received approval for use in cardiac, vascular and soft tissue reconstructions including a wide variety of surgical procedures involving the vasculature and major organs that entail bleeding or leakage.
Tenaxis Medical president and CEO Ronald Dieck said the company is very pleased to have been informed by its European Notified Body of the expanded indications for ArterX Surgical Sealant.
"It adds a new tool for the surgeon to assist in improving the care and outcomes for the patient," Dieck added.
"Application of ArterX Surgical Sealant to bleeding sites has been shown to reduce suture line bleeding. This has a direct impact on reduction of operating room and hospitalization times as well as loss of blood."