Cardiawave’s Valvosoft Secures CE Mark for Non-Invasive Aortic Stenosis Treatment

French medical technology company Cardiawave has received EU CE mark approval for Valvosoft, a non-invasive ultrasound therapy designed to treat patients with severe symptomatic aortic stenosis (sSAS). Valvosoft is the first device of its kind to offer a non-invasive treatment option for this condition, particularly for patients who are not eligible for procedures such as transcatheter aortic valve replacement (TAVR).

The CE mark follows the successful completion of first-in-human and pivotal clinical studies, which demonstrated the therapy’s feasibility, safety and lasting clinical benefits. Improvements in cardiac function and quality of life were maintained up to one year after treatment. Valvosoft uses focused, high-intensity ultrasound waves to soften and repair calcified aortic valves.

The pivotal study involved 100 elderly patients with multiple comorbidities across 12 European centres. Results showed a strong safety profile and significant improvements in blood flow. Cardiawave said the therapy provides a new option for patients who previously had no viable treatment alternatives.

18-12-2025