Vascular Insights is touting the results of an independent clinical trial examining the use of its ClariVein catheter to treat varicose veins.
The trial, conducted by Dr. Steve Elias of Mount Sinai Hospital in New York, indicated that the ClariVein procedure was as successful initially as radiofrequency or laser treatment, according to a press release.
Thirty patients with an average age of 55 participated in the trial. The out-patient treatments, which lasted an average 14 minutes, successfully closed 29 of 30 veins after six months. Another 22 patients were successfully treated after the end of the trial, according to the press release.
The device is a percutaneous infusion catheter that contains a rotating wire driven by a motor, according to the company’s website, used to irrigate peripheral blood vessels with therapeutic agents.
Vascular Insights won 510(k) clearance from the Food & Drug Administration to market ClariVein for percutaneous infusion applications. Spokesman Bill Kelly declined to comment when asked if the company plans pursue a new FDA clearance to market the product for the varicose vein indication.