Sapheon announced one year results in its first in-man safety trial of the Sapheon Closure system. At the one year mark, 100% of the great saphenous vein segments treated with this vein sealant remained completely closed by ultrasound criteria. All patients reported significant improvement in symptoms compared to baseline. No device or procedure related serious adverse events occurred at any interval over the follow-up period.
“The one year results represent a tremendous milestone for our company and technology. The data demonstrates that we can safely and effectively eliminate significant pain and symptoms related to superficial venous reflux disease while also eliminating procedural tumescent anesthesia, compression stockings, and extended recovery time.” Rodney Raabe, co-founder and chief medical officer of Sapheon said. “Each year more than one million new patients around the world require treatment of the saphenous vein. We are pleased that this large and growing patient population can benefit from our new technology.”
In a second study—a 30-patient, prospective, single-arm clinical trial of the Sapheon Closure system commenced in July 2011 and conducted by physician-investigators from the United States and Germany—similarly successful results are being obtained.
In December 2011, Sapheon commenced enrolment in the post-market study, eSCOPE (European Sapheon Closure system observational prospective) to be conducted at a major UK teaching hospital and leading private medical practices in Germany, The Netherlands and Denmark. The study will further evaluate saphenous vein closure and quality of life improvement measures with Sapheon Closure system.
The Sapheon Closure system is a CE mark approved advanced proprietary medical adhesive and single-use catheter-based delivery system that enables immediate and permanent closure of the saphenous vein without surgery, thermal ablation, or sclerosing chemicals.
The Sapheon Closure System will be formally launched in Europe and Asia in early 2012 under the trade name VenaSeal.