On 5/14/15 I wrote that the Venaseal procedure had been approved and would be available later this year. Venaseal is a patented catheter-based delivery system for “superglue” to ablate the saphenous vein causing surface varicosities without anesthesia or compression stockings. Its release was much anticipated due to these advantages over thermal ablation (TA) techniques. On the other hand, long-term outcomes are lacking and the procedure kit is very expensive. (Refer to our 5/14/15 blog)
Earlier this summer before its planned introduction in the U.S., the Venaseal system was recalled by the FDA because of a possible sterility breach in packaging which could cause patients treated with Venaseal to develop infections. Although no kits have been sold in the U.S. to date, they have been available in 14 other countries including Australia, Britain, and Europe where no instances of infection were reported.
The sterility factor has since been resolved and Venaseal kits are now available to physicians in the U.S. Although Venaseal has shown promising early results at one year comparable to the TA “gold standard,” many physicians are delaying adoption of Venaseal due to a lack of coding for insurance reimbursement and long-term durability. Here is a comparison of the current gold standard thermal ablation vs. Venaseal procedures.