Cardiawave’s Valvosoft Evaluated in FIH and Pivotal Studies

May 30, 2025—Cardiawave SA, a France-based medtech company, recently announced the presentation of the 12-month results from the Valvosoft first-in-human (FIH) study and the Valvosoft pivotal study evaluating the company’s noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic aortic stenosis (sSAS).

The company reported that the results confirm the findings for NIUT observed in earlier clinical studies.

Professor Hélène Eltchaninoff, MD, presented the data at the EuroPCR 2025 conference held May 20-23 in Paris, France. Prof. Eltchaninoff is Head of the Cardiology Department at Rouen University Hospital in Rouen, France.

According to the company, the two FIH studies that enrolled a total of 40 patients (N = 30; N = 10) demonstrated the safety and feasibility of the therapy.

Combined with the multicenter, prospective, single-arm pivotal study (N = 60), a total of 100 elderly patients with sSAS and multiple comorbidities were treated across 12 European centers in four countries.

The results showed the feasibility, safety, and efficacy of NIUT in treating sSAS. At 1 year after treatment, durable clinical benefits were observed, including improved cardiac function and significantly enhanced patient quality of life, reported the company.

The findings as outlined in Cardiawave’s press release included the following:

• 91% of patients were free of major adverse cardiac events (MACE) at 30 days, achieving the primary endpoint objective of MACE ≤ 25%.
• 85% of patients experienced an improvement or stabilization in their New York Heart Association class.
• An average nine-point improvement in the Kansas City Cardiomyopathy Questionnaire score, indicating a significant gain in quality of life.
• A 43% increase in aortic valve area at 12 months compared to the natural progression of the disease.

“These positive 12-month results confirm the ability of this innovative technology to significantly improve hemodynamics and patient quality of life in a completely noninvasive way,” commented Prof. Eltchaninoff during her presentation at EuroPCR, noted the Cardiawave press release. “This device is emerging as a serious long-term therapeutic option for aortic stenosis. These results also open the door to additional indications, such as [pre–transcatheter aortic valve replacement] preparation.”

Valvosoft is an investigational medical device and is not yet approved for commercial use in the European Union or the United States, advised Cardiawave.