August 21, 2011—Sapheon, Inc. (Santa Rosa, CA) recently announced successful enrollment of a 30-patient, prospective, single-arm clinical study of the Sapheon closure system. Sapheon is an early stage medical device company that develops treatment options for vascular disease, with a current focus on technology for the treatment of venous reflux disease.
[Editorial note: This 2011 story was incorrectly posted online and appeared in the August 28, 2012, edition of the Endovascular Today eNews. The correct story on Sapheon's August 10, 2012, announcement of 1-year data from the clinical study of the VenaSeal Sapheon closure system can be found here. We apologize for the error and any confusion.]
According to the company, the Sapheon closure system is a single-use, minimally invasive treatment for saphenous vein reflux disease. The device consists of a proprietary vein sealant and a custom delivery system that eliminates the need for deep tissue injections of tumescent anesthesia. The procedure is performed under ultrasound imaging guidance and requires only local anesthesia at the catheter entry site.
As summarized in the company’s announcement, the study was conducted by physician investigators from the United States and Germany at the Clinica Canela in the Dominican Republic under a local bioethics committee and government approvals, as well as US Food and Drug Administration clinical trial export permitting. The study is overseen by a United States-based data safety monitoring board and is being conducted to support the international regulatory approvals and marketing efforts of Sapheon.
Sapheon reported that in the study, complete closure of the great saphenous vein was accomplished with no adverse events in any patients. After the 20-minute treatment, all patients were fully ambulatory and released home with only a bandage. Twenty-nine patients who returned for monitoring 24 to 72 hours postprocedure were examined by ultrasound imaging; all treated vein segments remained closed, with no reports of discomfort or severe adverse events. Patients reported relief of venous reflux symptoms as early as 24 hours after the procedure.
In a statement issued in the company’s July 21 press release, the study’s Chief Clinical Investigator Jose I. Almeida, MD, of Vascular Device Partners (Miami, FL) commented, “Last week, we performed a carefully controlled cohort study of 30 patients with incompetent great saphenous veins and signs and symptoms of chronic venous disease. Thirty great saphenous veins were treated with a new proprietary medical adhesive. At the 24-hour follow-up, all veins were closed, and most notable was the absence of pain and ecchymosis in the treated areas. The procedures were easy to perform, and no complications were noted. Sapheon is currently in the process of obtaining a CE Mark for the product to commence sales in the outside-the-United States market. We anticipate that the product will be well received overseas.”
Sapheon also announced follow-up results in an eight-patient human safety trial that commenced in December 2010. At the 180-day follow-up visit, 100% of the treated great saphenous vein segments remained completely closed by ultrasound criteria. All patients reported a substantial reduction in symptoms compared to baseline, and there were no reports of device- or procedure-related adverse events.
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