High-intensity ultrasound technology for calcified valve leaflets makes debut in Europe
French company Cardiawave announced the first routine clinical use in Europe of its Valvosoft noninvasive ultrasound therapy (NIUT) since it received CE mark approval in late 2025. The technology uses high-intensity ultrasound to fragment leaflet calcium in severe symptomatic aortic stenosis. It was designed for patients who are not a good fit for surgical or transcatheter aortic valve replacement.
The company said this technology enables outpatient repair of the valve rather than replacement by restoring the mobility of the native valve without surgery or catheterization. By breaking up the valve leaflet calcifications for improved native leaflet motion, it preserves the surrounding tissue and improves hemodynamic performance without the use of general anesthesia.
“Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated. Valvosoft introduces a unique approach to restoring the mobility of the native valve without surgery or implantation. Clinical study results obtained in 100 patients confirm the feasibility, efficacy, and safety of this noninvasive therapy for patients who previously had no therapeutic option available,” Professor Emmanuel Messas, interventional cardiologist at Hôpital Européen Georges Pompidou and clinical investigator of the study, said in a statement.
The Valvosoft First-in-Human (FIM) Study and the Valvosoft Pivotal Study 12 month results of 100 patients treated across 12 European centers was presented at EuroPCR 2025. These studies confirmed both the safety of the technology and its effectiveness in improving cardiac function and patients’ quality of life.
Cardiawave is deploying the technology across multiple hospital centers in France, the Netherlands and Germany. It is also discussing distribution agreements across Europe, the United Kingdom, the Middle East and India. The company also plans entry into the U.S. market through the submission of an investigational device exemption (IDE) application.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]