Paris– French medtech firm Cardiawave has announced promising 12-month clinical outcomes from its ongoing evaluation of Valvosoft®, a non-invasive ultrasound therapy (NIUT) for treating severe symptomatic aortic stenosis (sSAS). The findings were presented at the EuroPCR 2025 Congress in Paris, underscoring the potential of this novel therapy to provide a safe, effective alternative for patients with limited treatment options.
The data, drawn from both the Valvosoft® FIM Study and the Valvosoft® Pivotal Study, showed that 91% of patients were free of major adverse cardiac events (MACE) at 30 days, meeting the study’s primary safety goal. Additionally, 85% of participants experienced either improved or stabilized symptoms based on their New York Heart Association (NYHA) classification. Patients also reported a notable 9-point average increase in their Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, reflecting a meaningful improvement in quality of life.
Importantly, the studies revealed a 43% average increase in aortic valve area (AVA) 12 months after treatment—an encouraging sign of sustained cardiac benefit.
The studies included 100 elderly patients across 12 European centers in four countries, many of whom had multiple comorbidities and were not eligible for conventional surgical or catheter-based interventions. The therapy’s non-invasive approach and favorable safety profile make it a potentially transformative option for a vulnerable patient population.
“These positive 12-month results confirm the ability of this innovative technology to significantly improve hemodynamics and patient quality of life in a completely non-invasive way,” said Professor Hélène Eltchaninoff, principal investigator of the study and head of the cardiology department at Rouen University Hospital. She also noted the potential for the therapy to support patients ahead of transcatheter aortic valve implantation (TAVI).
Currently, approximately 2.5 million people over age 75 in Europe and the U.S. suffer from sSAS, a life-threatening and progressive condition exacerbated by population aging. For many, especially those deemed inoperable or high-risk, no viable therapeutic alternative exists.
“These results are very encouraging,” said Cardiawave’s leadership in a statement. “They reinforce our mission to make this therapy available to as many patients as possible, including for new indications such as pre-TAVI preparation. We are now focused on the regulatory path in both Europe and the U.S., with a goal of launching commercially in Europe next year.”
Valvosoft® remains an investigational device and has not yet received regulatory approval for commercial use in either the European Union or the United States. (Source: IANS)
