The treatment from the Fridley, Minn.-based medical giant uses a proprietary medical adhesive to close superficial veins in lower extremities in patients with symptomatic venous reflux, or varicose veins.
“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. Kathleen Gibson of Seattle’s Lake Washington Vascular said in a press release.
To administer the adhesive, an operating physician inserts a catheter through an access site in the leg and guides it, with ultrasound, into diseased veins to administer the VenaSeal adhesive. Along with manual compression, the physician closes the vein so blood is rerouted through other healthy veins in the leg, Medtronic said.
“The VenaSeal procedure is shown to be safe and effective, with consistent results across 3 clinical trials. One-year results of the VeClose pivotal study, that led to the approval of VenaSeal closure system in the U.S., continue to demonstrate safety and efficacy of the procedure, with closure rates of 97.2%,” VeClose trial principal investigator Dr. Nick Morrison of Scottsdale, Ariz.’s Morrison Vein Institute said in prepared remarks.
The device is the 1st and only non-tumescent, non-thermal and non-sclerosant procedure for treating varicose veins in the U.S., Medtronic said.
“Medtronic today furthers our commitment to providing treatment options for patients with symptomatic venous reflux, a disease that can significantly impact quality of life. Thousands of patients have benefited from this procedure around the world, and we are pleased to now offer this advanced technology as an option to our U.S. physicians and patients,” Medtronic endovenous biz veep Sandra Lesenfants said in a prepared statement.
VenaSeal is currently cleared and available in the U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates and Hong Kong, Medtronic said.
Covidien, which is now owned by Medtronic, touted results of a study showing that its VenaSeal system is just as effective in treating chronic leg vein disorders as its ClosureFast ablation catheter back in November.