Cardiawave has announced that the first patients have been treated in routine clinical practice in Europe with Valvosoft, its non-invasive therapeutic system for the treatment of severe symptomatic aortic stenosis.
The milestone marks the beginning of the deployment of Valvosoft across France, the Netherlands, and Germany, the company says in a press release.
Valvosoft, which gained CE marking in December 2025, is intended for patients for whom immediate valve replacement—either transcatheter aortic valve implantation (TAVI) or surgical valve replacement (SAVR) —is not recommended, or who decline surgical intervention.
The system is designed to non-invasively restore leaflet mobility in a stenotic aortic valve and widen the valve opening to relieve patient heart failure symptoms. High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.
“The rollout of Valvosoft following CE mark approval represents a major milestone for Cardiawave and for patients suffering from severe symptomatic aortic stenosis,” Carine Schorochoff, the company’s CEO, commented. “We can now offer a non-invasive treatment option to patients for whom immediate valve replacement is either not feasible or not desired. This achievement also marks Cardiawave’s transition into a new phase of growth, driven by the deployment of Valvosoft across several European countries and our ambition to become a leading player in the non-invasive treatment of aortic stenosis.”
Twelve-month results from the Valvosoft first-in-human (FIH) study and the Valvosoft pivotal study, presented at EuroPCR 2025, involving 100 patients treated across 12 European centres, demonstrated both the safety of the technology and its effectiveness in improving cardiac function and patients’ quality of life.
“Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated. 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 non-invasive therapy for patients who previously had no therapeutic option available,” said Emmanuel Messas (Hôpital Européen Georges Pompidou AP-HP, Paris, France), a clinical investigator in the study.
The company states that, since May 2026, several Valvosoft systems have been placed into clinical use, with a progressive rollout across centres in France and throughout Europe. Distribution agreements are currently under discussion across Europe, the UK, the Middle East, and India.
Cardiawave is initially targeting approximately 300,000 patients in Europe and the USA who are either ineligible for immediate aortic valve replacement or unwilling to undergo such procedures. The company is preparing its entry into the US market through the submission of an investigational device exemption (IDE) application.
