A medical adhesive and single-use catheter-based delivery system, designed to treat saphenous vein reflux disease, has demonstrated efficacy in a one year follow-up first in-man safety trial.
The CE-marked Sapheon Closure System enables immediate and permanent closure of the saphenous vein without surgery, thermal ablation or sclerosing chemicals.
It comprises of a proprietary vein sealant and custom delivery system that eliminates the need for painful and time consuming deep tissue injections of tumescent anesthesia.
The catheter-based, single-use disposal medical device uses vein closure technology to close and eliminate the saphenous vein without burning or the use of harsh chemicals. At the one year follow-up tests, all the patients reported considerable improvement in symptoms.
Sapheon co-founder and chief medical officer Rodney Raabe said: "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. 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."
The 30-patient clinical trial carried out in July 2011 reported that all of the participants showed complete closure of the great saphenous vein was achieved with no adverse effects , they were then allowed to go home immediately post-procedure, with only a plaster after the 20 minute treatment.
In December 2011, the company began patient enrolment in a post-market study, the European Sapheon Closure System Observational ProspectivE (eSCOPE) trial, to further evaluate the saphenous vein closure and quality of life improvement measures with the system.
The device will be launched in Europe and Asia in early 2012 under the trade name VenaSeal.
Image: saphenous vein reflux disease results in enlarged and tortuous veins, that prevent blood from flowing backwards. Photo: Jackerhack.