Tenaxis Medical, Inc., (www.tenaxismedical.com), a medical device company focused on the development of functionally designed surgical sealants has received approval from its EU Notified Body, BSI, to expand its CE Mark indications for ArterX Surgical Sealant.
ArterX Surgical Sealant is designed to be applied directly over suture or staple line to achieve hemostasis during surgery to seal the area to stop and prevent leaks. The intended use for the product has now been expanded for use in cardiac, vascular and soft tissue reconstructions. This includes a wide variety of surgical procedures including the vasculature and major organs that involve bleeding or leakage.
Approved CE Mark indications and usage specified in the new product labeling include:
Aortic root replacement, aortoplasty, aortic valve procedures, valve procedures, Bentall procedure, composite valve conduit procedure, mitral valve replacement, Ross procedure, proximal coronary anastomoses, aortic aneurysm repairs, aortic wall replacement, ascending aorta repair.
Peripheral Vascular Reconstructions
Aorto-femoral bypass, aorto-iliac bypass, aortic bypass, aorto-innominate bypass, carotid bypass, carotid endarterectomy, femoral-distal bypass, femoral-femoral bypass, femoral-popliteal bypass, hepatic-renal bypass, popliteal-dorsalis pedis bypass, profunda endarterectomy, renal bypass, extremity bypass, renal endarterectomy, hemodialysis access, arteriovenous graft.
Soft Tissue Repair Involving Sutures and Staples
Cardiac wound repair, pancreatic anastomotic leak, hepatic resection, splenic bleeding, biliary leaks, esophageal repair, colorectal repair, stapled gastrojejunostomy and lymphatic leaks.
"We are very pleased to have been informed by our 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," commented Ronald Dieck, President and Chief Executive Officer of Tenaxis Medical. "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."