FDA Approves the VenaSeal(TM) Closure System for Treatment of Clinically Symptomatic Venous Reflux
VenaSeal Closure System, a Next-Generation Chronic Venous Insufficiency Procedure with Demonstrated Safety and Effectiveness
DUBLIN – Feb. 24, 2015 - Medtronic plc today announced U.S. Food and Drug Administration approval for VenaSeal(TM) closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such as the great saphenous vein in patients with symptomatic venous reflux.
Venous reflux disease, also known as chronic venous insufficiency, occurs when valves in the veins of the lower leg no longer function properly. This allows blood to flow backward, or reflux, resulting in enlarged, or varicose veins as well as other symptoms. If left untreated, the condition can progress and, in severe cases, can result in lifestyle-limiting lower leg pain, swelling, skin damage and ulcerations.
The VenaSeal procedure is the only non-tumescent, non-thermal, non-sclerosant procedure approved for use in the U.S. that uses a specially formulated medical adhesive that closes the vein. This unique approach may eliminate the risk of nerve injury that is sometimes associated with certain thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. Patients also report minimal-to-no bruising post procedure.
“The VenaSeal system is an advanced varicose vein procedure that delivers results that are comparable to current methods,” said Dr. Nick Morrison, national principal investigator of the VeClose Trial, Morrison Vein Institute, Scottsdale, Ariz. “As the patient does not require multiple injections of a local anesthetic (tumescent anesthesia), there is minimal to no bruising and patients are often able to quickly return to normal activities.”
Source: www.medtronic.com; February 24, 2015.