Cardiawave has announced the first patients treated in Europe with its Valvosoft platform, following the system’s CE mark approval for severe symptomatic aortic stenosis (sSAS).
Valvosoft uses non-invasive focused ultrasound therapy to restore movement in narrowed aortic valve leaflets. The technology targets calcium buildup in the valve using ultrasound waves, aiming to improve valve opening and heart function without surgery or general anesthesia.
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The treatment is designed as an alternative option for patients who may not be suitable for or do not want traditional valve replacement procedures such as TAVR.
Cardiawave is now beginning a European rollout across France, the Netherlands, and Germany, while preparing future regulatory steps for the U.S. market.
CEO Carine Schorochoff said:
“We can now offer a non-invasive treatment option to patients for whom immediate valve replacement is either not feasible or not desired.”
The milestone marks Cardiawave’s transition from development into clinical deployment of its ultrasound-based approach for heart valve disease.
