Sapheon has reported one year follow-up data from a clinical study of its VenaSeal Sapheon closure system, designed to treat saphenous vein disease.
VenaSeal system, which comprises a proprietary vein sealant and custom delivery system, uses the proprietary medical adhesive to close the saphenous vein, therefore eliminating the need for surgery, ablation, sedatives, anesthesia and use of harsh chemicals.
The procedure is performed under ultrasound imaging guidance and requires only local anesthesia at the catheter entry site, according to the company.
The study has enrolled 38 patients and treated them without the use of general or tumescent anesthesia or post-procedure compression stockings.
Results demonstrated that all patients returning for follow up experienced clinical improvement at 1, 3, 6, and 12 months with complete closure rate of more than 94% after one year.
Rod Raabe, Sapheon chairman and chief medical officer, said the VenaSeal Sapheon closure system is designed to address the more than 1,000,000 new patients each year who undergo invasive and painful surgery or ablation procedures.
"We believe that the VenaSeal System is the future for treating venous reflux disease," Raabe added.
Dr. Jose I. Almeida, Vascular Device Partners spokesperson and study chief clinical investigator, said 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," Almeida added.
St. Petersburg general and vascular surgeon Dr. Edward Mackay said: "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."
Image: VenaSeal system uses the proprietary medical adhesive to close the saphenous vein. Photo courtesy of: Sapheon, Inc.