Medtronic Launches the VenaSeal Closure System to Treat Venous Reflux in United States

November 9, 2015—Medtronic plc announced the launch of the VenaSeal closure system in the United States. The VenaSeal system provides a nontumescent, nonthermal, nonsclerosant procedure approved for the treatment of symptomatic venous reflux. VenaSeal was approved by the US Food and Drug Administration in February 2015 and is currently available in the United States, New Zealand, Chile, South Africa, Australia, Canada, Europe, the United Arab Emirates, and Hong Kong.

According to Medtronic, VenaSeal uses an adhesive to close superficial veins of the lower extremities, such as the great saphenous vein, in patients with symptomatic venous reflux.

In the procedure, an ultrasound-guided catheter is inserted through a small access site in the leg and directed into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, closing the vein with manual compression. Blood is rerouted through other healthy veins in the leg.

This approach aims to eliminate the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal to no pain or bruising after the procedure, advised Medtronic.

Nick Morrison, MD, from the Morrison Vein Institute in Scottsdale, Arizona, served as National Principal Investigator of the pivotal VeClose trial. Dr. Morrison commented in the company’s press release, “The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials. One-year results of the VeClose pivotal study, [which] led to the approval of VenaSeal closure system in the United States, continue to demonstrate safety and efficacy of the procedure, with closure rates of 97.2%.”

On October 21, Kathleen Gibson, MD, of Lake Washington Vascular in Seattle, Washington, performed the first treatment of a patient in the United States with the VenaSeal closure system since approval. Dr. Gibson commented in the company’s press release, “Patients are often told their varicose veins are only a cosmetic issue, but varicose veins are a sign of a condition known as venous insufficiency, which can cause symptoms that impact quality of life, and over time can lead to more serious problems. Left untreated, the venous insufficiency often progresses and can cause leg pain, leg and ankle swelling, leg heaviness and fatigue, skin changes or rashes, ulcers and open wounds.”

Dr. Gibson continued, “The first patient is an active, tennis-playing mother of three with a family history of varicose veins. After careful diagnosis and evaluation of various treatment options, she and I decided VenaSeal was the right choice of treatment for her. She reported no pain during the procedure and was able to return to normal activities quickly after the treatment. She left the office with a single adhesive bandage at the site of treatment, and without postprocedure compression stockings.”