MORRISVILLE, N.C.--(BUSINESS WIRE)--Sapheon Inc. announced completed enrollment and first follow-up data in its European Sapheon Closure System Observational ProspectivE (eSCOPE) study. The single-arm, multi-center post-market study includes nine physicians at seven sites treating 67 patients from the UK, Germany, Demark and The Netherlands. Sapheon’s VenaSeal treatment uses a proprietary medical adhesive and delivery system to close the saphenous vein, eliminating the need for surgery, ablation, sedatives, anesthesia, post procedure compression stockings, and the use of chemical sclerosants.
According to Sapheon, all procedures were successful at the time of treatment with 100% closure by ultrasound criteria. To date, sixty patients completed 30-day follow-up visits and twenty-six patients completed 90-day follow-up visits with 100% and 96% closure rates, respectively. No serious adverse events have been reported in the study. These results are consistent with the one year data in its 38-patient human feasibility study reported earlier this summer by Sapheon.
According to eSCOPE investigator Dr. Jens Alm, Dermatologikum Hamburg, Germany, “My impression is that patients have a better quality of life experience after the VenaSeal procedure compared to thermal ablation vein techniques. My patients had no post-procedure discomfort and did not require uncomfortable compression stockings. They were able to return to normal day-to-day activities immediately.”
“The results of our eSCOPE study indicate that VenaSeal delivers a patient friendly treatment option,” said Rod Raabe, M.D., Chairman and Chief Medical Officer of Sapheon. “The VenaSeal Sapheon Closure System is clearly an effective treatment which eliminates the significant pain, tumescent anesthesia, compression stockings, and extended recovery time associated with ablation therapies. We now look forward to offering physicians this improved procedure for treating patients suffering from a common medical condition that results in painful varicose veins and unsightly legs.”
About Sapheon
Sapheon Inc. is a privately held medical device company whose mission is to develop new approaches for the treatment of vascular disease. The Company’s current focus is on an advanced treatment option for venous reflux disease, a $1 billion worldwide market. Sapheon has obtained European Union regulatory approval for the VenaSeal™ Sapheon® Closure System. The VenaSeal Sapheon Closure System is not commercially available in the United States. Please visit www.sapheoninc.com to learn more about Sapheon.
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