French medtech company Cardiawave has gained an EU CE mark for its non-invasive ultrasound therapy (NIUT) Valvosoft, marking the first device of its kind available to patients with a form of heart disease.
Valvosoft has been authorised to treat patients with severe symptomatic aortic stenosis (sSAS) who may be ineligible for other treatments such as transcatheter aortic valve replacement (TAVR).
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Valvosoft’s receipt of CE marking follows the recent completion of its first-in-human and pivotal studies for the system. According to Cardiawave, each study demonstrated the feasibility, safety, and clinical benefits of the therapy, with durable improvements observed one year after treatment, including enhanced cardiac function and significantly better patient quality of life.
The technology works by using focused, high-intensity therapeutic ultrasound pulses to soften and repair calcified aortic heart valves.
Cardiawave CEO Carine Schorochof commented: “Innovating to address unmet patient needs is at the heart of Cardiawave’s mission. We are therefore extremely proud to have received CE certificate for our first-of-its-kind NIUT for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement or refusing such intervention.
“With CE marking of our Valvosoft system, we can now provide a much-needed treatment option for patients.”
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By GlobalDataValvosoft’s pivotal study enrolled 100 elderly, highly comorbid patients across 12 European sites.
Professor Christian Spaulding, director of interventional cardiology at the Hôpital Européen Georges Pompidouin Paris, France and the study’s coordinating investigator said: “The Valvosoft pivotal study has demonstrated a strong safety profile and has shown its 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 are now offering a therapy to many patients who previously had no treatment options.”
In sSAS patients, the aortic valve narrows, restricting blood flow from the heart to the body. While TAVR has been an area of considerable buzz in recent years for treating the condition, research indicates that up to 16% of patients may be ineligible for the procedure. Eliminating factors for TAVR may include age, overall health, and individuals’ anatomic makeup.
Edward Lifesciences continues to be a guiding force in the TAVR space that is forecast to reach a $12.58bn valuation by 2034, as per GlobalData analysis.
According to GlobalData analysis, the company holds more than 60% of the global TAVR market share and 75% in the US.
