The France-based medtech company designed Valvosoft for the treatment of severe symptomatic aortic stenosis (sSAS). It aims to non-invasively restore leaflet mobility in a stenotic aortic valve. It widens the valve opening to relieve the patient’s heart failure symptoms. High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue.
Dr. Hélène Eltchaninoff, head of cardiology at Rouen University Hospital and principal investigator of the study, presented 12-month findings from the Valvosoft FIM study and Valvosoft pivotal study at EuroPCR 2025 in Paris.
Following two first-in-human studies and a multicenter pivotal study, the treatment has demonstrated feasibility, safety and efficacy. At one year post-treatment, investigators saw durable clinical benefits, including improved cardiac function and enhanced quality of life.
According to a news release, 91% of patients proved free from major adverse cardiac events (MACE) at 30 days. That adverse event rate of 9% achieved the primary endpoint of MACE coming in less than or equal to 25%.
Eltchaninoff said the results “confirm the ability” of the technology in improving hemodyanmics and quality of life in a non-invasive way. The clinician said it could emerge as a serious long-term therapeutic option for aortic stenosis. Additionally, according to Eltchaninoff, results could open the door to more indications, like pre-TAVI preparation.
Valvosoft remains investigational in both the U.S. and in Europe.
“These results are very encouraging. They reinforce our determination to make this non-invasive therapy accessible to as many people as possible, including for complementary indications such as pre-TAVI preparation,” said Cardiawave’s leadership team. “We are excited to move forward with regulatory steps in Europe and the United States, aiming for a European market launch next year.”
