One-Year Data Support Sapheon's Closure System for Varicose Vein Treatment

August 31, 2012—Sapheon, Inc. (Santa Rosa, CA) recently announced 1-year data from a 38-patient clinical study of the VenaSeal Sapheon closure system for the treatment of saphenous vein disease. The VenaSeal system consists of Sapheon's vein sealant and delivery system that eliminate the need for deep tissue injections of tumescent anesthesia. The procedure is performed under ultrasound guidance and requires only local anesthesia at the catheter entry site, the company stated.

According to Sapheon, all patients were treated without the use of general or tumescent anesthesia or postprocedure compression stockings. All patients returning for follow-up experienced clinical improvement at 1, 3, 6, and 12 months, with a complete closure rate of > 94% after 1 year. 

In the company's August 10 press release, the study's Chief Clinical Investigator Jose I. Almeida, MD, of Vascular Device Partners (Miami, FL) commented, “Nonthermal (VenaSeal) adhesive technology for the treatment of saphenous vein incompetence is proving to be safe and durable. At 1-year follow-up, the results of this study are quite comparable to methods using thermal ablation.” 

Edward Mackay, MD, a study investigator, 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 1 year postoperatively. This has the potential to change the way varicose veins are treated.” 

[Correction: In the August 28, 2012, edition of the Endovascular Today eNews and online News section, a story on Sapheon, Inc.'s VenaSeal closure system reported on the company's completion of trial enrollment, which was based on a July 2011 press release. The above story is the correct, current coverage of the company's recent report of the study's 1-year data. We apologize for the error and any confusion.]