Jessica Perry//June 1, 2022//
According to Englewood Health, at least 3 out of every 10 people experience varicose veins in their lifetime. To help turn the tide on treatment for the condition, the hospital said June 1 it is the first and only site in the U.S. to offer Sonovein echotherapy: a new, no-incision, no-scar procedure for patients.
At the beginning of May, Englewood entered its first four patients into the trial for the new therapy. Not only are they the first at the hospital, but the group marks the first patients in the U.S. to undergo the treatment, which requires no anesthesia or infiltration.
Surrounding muscles, vein walls and valves work together in a healthy leg vein to bring blood back — against gravity — toward the heart. When vein valves cease to function correctly, or the elasticity of vascular walls weakens, blood can build up in the legs, causing enlarged vein walls and varicose veins.
The single-center study is planned for 20 patients with diagnosed symptomatic primary great saphenous vein (GSV) insufficiency. Eligible participants will undergo a one-day Sonovein treatment including:
Follow-up visits are scheduled for one week and three months after treatment to evaluate changes in veins and flow characteristics. Participation is free for qualified patients. Contact Dr. Steven Elias at Englewood’s Center for Vein Disease at (201) 894-3252 for more information.
Symptoms of the ailment include itchy, swollen or heavy-feeling legs. According to Englewood Health, left untreated symptoms can worsen and lead to leg ulcers or other complications.
Sonovein is made by Theraclion. The French company received approval from the U.S. Food & Drug Administration for Sonovein’s first U.S. trial in September 2021. In a statement, Dr. Michel Nuta, chief medical officer and vice president, veins at Theraclion SA, said a full pivotal study will be conducted for FDA review following the trial.
According to Englewood Health, Sonovein is the only completely noninvasive treatment option for varicose veins using echotherapy to treat the damaged vessels from outside the body. That procedure utilizes high-intensity focused ultasound (HIFU) waves to target veins and generate thermal energy, as it is delivered to the veins, they shrink and are ultimately sealed closed.
Theraclion said the first patients to be treated with Sonovein received care from vein specialists Drs. Steven Elias, Nicos Labropoulos and Antonios Gasparis. Elias is director of the Center for Vein Disease at Englewood Health.
“We appreciate the opportunity to be the first and only hospital to trial this technology for this indication,” he stated. “But more importantly, we really appreciate our patients for participating and helping to improve vein care for all.”
According to Theraclion, the trial is part of the company’s strategy to focus on key markets, with the U.S. representing the largest for varicose veins with an estimated 2.3 million procedures representing $5 billion in health care spending. As of April 20, 1,000 patients had been treated with the non-invasive therapy across Europe and Asia.