Cardiawave’s Valvosoft NIUT Device to Treat Severe Symptomatic Aortic Stenosis Launched in Europe

June 16, 2026—Cardiawave, a French medtech developer of noninvasive ultrasound therapies (NIUTs) for the treatment of aortic stenosis, announced the commencement of a large-scale launch of the Valvosoft device in Europe. The first patients treated in routine clinical practice in Europe with Valvosoft mark the beginning of the deployment of the device across France, the Netherlands, and Germany.

The company advised that since May 2026, several Valvosoft systems have been placed into clinical use with a rollout across multiple hospital centers in France and throughout Europe. Distribution agreements are currently under discussion across Europe, the United Kingdom, the Middle East, and India, noted Valvosoft.

In December 2025, the company announced CE Mark approval for Valvosoft for NIUT to treat severe symptomatic aortic stenosis. Cardiawave advised is also preparing its entry into the United States market through the submission of an investigational device exemption application.

According to Cardiawave, the Valvosoft technology restores the mobility of the native valve without surgery or implantation by using high-intensity ultrasound pulses to fragment calcifications on the valve leaflets while preserving surrounding tissues. It is intended for patients for whom immediate valve replacement—either via transcatheter aortic valve replacement or surgical aortic valve replacement—is not recommended, or who decline surgical intervention.

The press release noted that 12-month results from the Valvosoft First-in-Human Study and the Valvosoft Pivotal Study composed of 100 patients treated across 12 European centers confirmed both the safety and effectiveness in improving cardiac function and patients’ quality of life. The data were presented at EuroPCR 2025.

Professor Emmanuel Messas, MD, who is an interventional cardiologist at Hôpital Européen Georges-Pompidou in Paris, France, and serves as a clinical investigator of the combined study, discussed the device in the Cardiawave’s press release.

“Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated,” stated Prof. Messas. “Valvosoft introduces a unique approach: 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.”