US clinical trial results for Tenaxis' investigational vascular surgical sealant, ArterX, were presented today at the Veith Meeting in New York. William M. Stone, MD of the Mayo Clinic, Scottsdale AZ reported a more than 20% margin of improvement for ArterX Surgical Sealant in the sealing of vascular suture lines compared with a control group featuring a commercially available gelatin foam/thrombin combination.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial. We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
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