SANTA ROSA, Calif.--(BUSINESS WIRE)--Sapheon Inc. announced one year data in a 38-patient clinical study of the VenaSeal™ Sapheon® Closure System, an advanced approach to the treatment of saphenous vein disease based on a proprietary medical adhesive. All patients were treated without the use of general or tumescent anesthesia or post-procedure compression stockings, and all patients returning for follow up experienced clinical improvement at 1, 3, 6, and 12 months with complete closure rate of over 94% after one year.
According to the study’s chief clinical investigator, Dr. Jose I. Almeida of Vascular Device Partners, Miami, Florida, “Non-thermal [VenaSeal] adhesive technology for the treatment of saphenous vein incompetence is proving to be safe and durable. At one-year follow-up, the results of this study are quite comparable to methods using thermal ablation.”
Dr. Edward Mackay, St. Petersburg, Florida, who also participated in this study, added “My experience with the VenaSeal System has been very positive based on ease of use and patient tolerance both during the procedure and up to one year post operatively. This has the potential to change the way varicose veins are treated.”
“The VenaSeal Sapheon Closure System was designed to address the more than 1,000,000 new patients each year who undergo invasive and painful surgery or ablation procedures,” said Rod Raabe, M.D., Chairman and Chief Medical Officer of Sapheon. “We believe that the VenaSeal System is the future for treating venous reflux disease.”
The VenaSeal Sapheon Closure System consists 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 procedure is performed under ultrasound imaging guidance and requires only local anesthesia at the catheter entry site.
Sapheon Inc. is a privately held medical device company whose mission is to develop new approaches and disruptive technologies for the treatment of vascular disease. The Company’s current focus is on an advanced treatment option for venous reflux (saphenous vein) disease, a $1 billion worldwide market. Sapheon has fully developed and obtained European Union regulatory approval for the VenaSeal™ Sapheon® Closure System. The VenaSeal System uses a proprietary medical adhesive to close the saphenous vein, eliminating the need for surgery, ablation, sedatives, anesthesia, and the use of harsh chemicals. The VenaSeal Sapheon Closure System is not commercially available in the United States at this time. Please visit www.sapheoninc.com to learn more about Sapheon.
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