Tenaxis Medical, Inc., a medical device company founded in 2004 to bring high performance surgical sealants to the vascular and general surgical markets, announced that vascular surgeons at the Krankenhaus Friedrichstadt in Dresden, Germany were the first to clinically use their novel high performance vascular sealant, ArterX(TM).
The investigational product was used on a 74 year old man suffering from vascular insufficiency of the leg requiring the implant of a synthetic vascular bypass graft. This is a procedure that is usually accompanied by profuse bleeding at the suture lines and requires the physician to use manual pressure for up to 30 minutes to stop the bleeding. The sealant, which has been designed to cure in 15 seconds, was applied over the top of the suture line and immediately stopped the bleeding through the needle holes created when the artificial graft was sutured in place and the artery-graft junction was exposed to full arterial pressure.
AdvertisementDr James Zimmerman, a vascular surgeon with Pacific Coast Cardiac & Vascular Surgeons, Redwood City, California, attended the first surgery and said "the procedure went flawlessly, the product was deployed over the top of the sutures, and on clamp release there was absolutely no bleeding." This is the first of up to 60 procedures that are anticipated to be conducted in Germany. Procedures are also underway in hospitals in Ulm and Cologne and the study is expected to be fully enrolled by the end of the summer.
The ArterX Vascular Sealant was developed by Tenaxis Medical's team in Mountain View, CA and is based upon a proprietary technology that uses a powerful crosslinking agent that covalently binds to proteins in both the sealant and human tissue. "I am extremely proud of the progress the team has achieved in developing a meaningful new generation of vascular sealants," said Ronald Dieck, President and CEO of Tenaxis Medical, Inc. "This is the first step in a comprehensive clinical program to position this product for regulatory clearance and subsequent launch in Europe in early 2008, and in the USA in early 2009.