Cardiawave obtains EU approval for the first non-invasive ultrasound therapy for severe aortic stenosis.

FRANCE— French medical technology company Cardiawave has received EU CE mark approval for Valvosoft, an innovative non-invasive ultrasound therapy that represents the first device of its kind available to patients with severe heart disease.

The company has gained authorization to treat patients with severe symptomatic aortic stenosis who cannot undergo other treatments such as transcatheter aortic valve replacement.

Cardiawave recently completed its first-in-human and pivotal studies for the system, which demonstrated the feasibility, safety, and clinical benefits of the therapy.

Both studies showed durable improvements one year after treatment, including enhanced cardiac function and significantly better patient quality of life.

 The technology employs focused, high-intensity therapeutic ultrasound pulses to soften and repair calcified aortic heart valves.

Carine Schorochoff, CEO of Cardiawave, emphasized that addressing unmet patient needs drives the company’s mission.

She expressed pride in receiving the CE certificate for this first-of-its-kind non-invasive ultrasound therapy for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement or refuse such intervention.

With CE marking secured, the company can now provide a much-needed treatment option for these patients.

The pivotal study enrolled 100 elderly patients with multiple health conditions across 12 European sites.

Professor Christian Spaulding, director of interventional cardiology at the Hôpital Européen Georges Pompidou in Paris and the study’s coordinating investigator, noted that the Valvosoft pivotal study demonstrated a strong safety profile.

The study showed the therapy’s ability to improve haemodynamic parameters in patients suffering from symptomatic severe aortic valve stenosis who are not eligible for immediate valve replacement.

The improvements in patients’ quality of life now offer therapy to many patients who previously had no treatment options.

In patients with severe symptomatic aortic stenosis, the aortic valve narrows and restricts blood flow from the heart to the body.

While transcatheter aortic valve replacement has generated considerable attention in recent years for treating the condition, research indicates that up to 16% of patients may be ineligible for the procedure.

Eliminating factors for the procedure include age, overall health, and individuals’ anatomic makeup.

Edward Lifesciences continues to lead the transcatheter aortic valve replacement space, which GlobalData analysis forecasts will reach a $12.58 billion (€11.86 billion) valuation by 2034.

 According to GlobalData analysis, the company holds more than 60% of the global market share and 75% in the United States.