Cardiawave’s Valvosoft Approved in Europe for Treatment for Severe Symptomatic Aortic Stenosis

December 4, 2025—Cardiawave announced it has received CE Mark approval for Valvosoft noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic aortic stenosis (sSAS).

According to the company, the European approval comes after the 24-month results from Cardiawave’s Valvosoft first-in-man (FIM) study and the 12-month results from the Valvosoft pivotal study that evaluated NIUT with Valvosoft to treat sSAS. The studies were composed of 100 elderly, highly comorbid patients enrolled at 12 European centers in four countries.

Cardiawave reported that the studies demonstrated the feasibility, safety, and clinical benefits of the therapy with durable improvements observed at 1 year after treatment, including enhanced cardiac function and significantly better patient quality of life. In May 2025, the company announced that the 12-month results from the Valvosoft FIM and Valvosoft pivotal studies were presented at the EuroPCR 2025 conference.

“The Valvosoft pivotal study has demonstrated a strong safety profile and has shown its ability to improve hemodynamic parameters in patients suffering from symptomatic severe aortic valve stenosis who are not eligible for immediate valve replacement,” commented Professor Christian Spaulding, MD, who serves as Coordinating Investigator for the Valvosoft pivotal study, in the company’s press release. “The improvements in patients’ quality of life are now offering a therapy to many patients who previously had no treatment options.” Prof. Spaulding is Director of Interventional Cardiology, Hôpital Européen Georges Pompidou—AP-HP, in Paris, France.

Valvosoft is an investigational medical device that is not yet approved for commercial use in other countries or areas including the United States, advised Cardiawave.