Tenaxis Medical Receives CE Mark
Tenaxis Medical®, Inc. Receives CE Mark Approval to Expand Indications for Its ArterX® Surgical Sealant
MOUNTAIN VIEW, Calif., Sept. 6, 2013 /PRNewswire/ -- 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."
About Tenaxis Medical, Inc.
Located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company that began operations in 2006. It develops novel, high performance sealants that are designed to meet unmet needs throughout various medical procedures. The products are based on a patent foundation that allows for the development of sealants with wide mechanical and chemical properties.
In addition to ArterX Surgical Sealant, which is commercially available in the US and Europe, Tenaxis is developing other functionally designed products to meet key medical needs. These include a second high-performance sealant, Prevent(TM) GI Sealant, for use throughout the gastrointestinal tract, and an anti-surgical adhesion agent, PeriGlide Adhesion Prevention that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
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SOURCE Tenaxis Medical, Inc.
Tenaxis Medical, Inc.
Web Site: http://www.sealantsbydesign.com
Posted: September 2013