ATLANTA – A cyanoacrylate adhesive–based implant is feasible, safe, and effective for the treatment of great saphenous vein incompetence, according to 1-year follow-up data from the first study of the product in humans.
The treatment requires neither local anesthesia nor use of medical compression stockings, Dr. Thomas Proebstle reported at the annual meeting of the American Society for Dermatologic Surgery.
Of 38 patients with an incompetent great saphenous vein who were treated with a proprietary formulation of cyanoacrylate adhesive (commonly known as superglue), 100% demonstrated complete closure of the vein immediately and at the 48-hour follow-up, as measured using duplex ultrasound and clinical examination; at 1-year follow-up, 92% maintained complete closure of the vein, said Dr. Proebstle of Hirschberg, Germany. One complete recanalization and two partial recanalizations occurred during follow-up – at 1, 3, and 6 months, respectively, he noted.
Most patients (89%) had improvement in leg edema within 48 hours, and all had venous clinical severity score improvement, which changed from a mean of 6.1 at baseline to a mean of 1.1 at 6 months.
The study involved 29 women and 9 men with a median age of 51 years. Treatment was administered by catheter deployment under ultrasound guidance via a repetitive bolus injection algorithm, Dr. Proebstle noted. No tumescent anesthesia or compression stockings were used.
For this study, the mean total volume of endovenous cyanoacrylate adhesive delivered was 1.26 mL. Side effects were mild and self-limited.
The cyanoacrylate adhesive implant, known as the VenaSeal Sapheon closure system, has received European Union regulatory approval. The manufacturer, Sapheon, is currently preparing for U.S. clinical trials and Food and Drug Administration approval, according to the company’s website.
Dr. Proebstle is a consultant for Sapheon. He also owns stock in the company.