FDA approves Medtronic’s VenaSeal closure system to treat varicose veins

22 February 2015 (Last Updated February 22nd, 2015 18:30)

Medtronic has received approval from US Food and Drug Administration (FDA) for the VenaSeal closure system.

Leg

Medtronic has received approval from US Food and Drug Administration (FDA) for the VenaSeal closure system.

It is the first device that uses adhesive to cut off blood supply in the treatment of superficial varicose veins of the legs.

The VenaSeal sterile kit includes an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guide wire, dispenser gun, dispenser tips, and syringes.

FDA Center for Devices and Radiological Health, Office of Device Evaluation acting director Dr William Maisel said: "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.

"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."

Approval was granted after the FDA reviewed data for the VenaSeal system in a premarket approval application, which included results from three clinical studies.

In the US clinical study, the VenaSeal system's safety and effectiveness was assessed in 108 participants compared to radiofrequency ablation in 114 participants.

The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs. It received regulatory approval in Europe in 2011.

The VenaSeal closure system is manufactured by Covidien, which was purchased by Medtronic for $43bn in January.


Image: A person affected by varicose veins. Photo: courtesy of Wikimedia Commons user self.