Madison, CT based Vascular Insights LLC has released data from the first clinical trial of its ClariVein infusion catheter. The FDA cleared device allows for the treatment of varicose veins with a minimally invasive outpatient procedure in which a sclerotherapy agent is delivered to the affected site via a catheter.
From the press release:
Thirty patients with an average age of 55 were part of this first-in-man trial. Most patients had symptomatic varicose veins, with some having more advanced vein disease such as swelling and skin changes. Mean vein diameter was 8.1 mm. Treatment for each vein averaged 5 minutes and overall procedure time was 14 minutes.
At six-month follow-up, 29 of the 30 veins treated were successfully closed. The only vein that did not respond was that of the first patient. Subsequent to the trial, to date 22 other patients have had the ClariVein® procedure, with all being successful.
Press release: ClariVein(R) Catheter for Varicose Veins: Clinical Trial Final Results Announced…
Product page: ClariVein…
