Last year Covidien acquired vascular device start-up business, Sapheon, Inc., with its VenaSeal vessel closure system. Now the U.S. FDA has approved the VenaSeal closure system for the permanent treatment of varicose veins of the legs using an adhesive agent.
Background
We’ve followed VenaSeal for a while now, most recently when Covidien reported very high closure rates from its pivotal study last November (2014).
Varicose veins are the result of weak or damaged valves within the superficial vasculature, this causing blood to back up and pool, giving rise to those characteristically enlarged, swollen or twisted veins.
Current treatments include compression stockings or surgical removal or closure of the affected veins. VenaSeal offers another way though, comprising a cyanoacrylate glue that is delivered into the offending vessel using a system including a catheter, guidewire, dispenser gun, dispenser tips, and syringes. In essence, a trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
FDA comments
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
Source: FDA
published: February 23, 2015 in: Approval/Clearance, Covidien, Plastic/Reconstructive