Tenaxis Medical earns EU approval to expand CE Mark indications for ArterX Surgical Sealant

Published on September 7, 2013 at 6:34 AM · No Comments

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:

Cardiac Reconstructions
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.

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