LEVALLOIS-PERRET, France — Cardiawave, a medtech company developing non-invasive ultrasound therapy for aortic stenosis, has received CE Marking for Valvosoft, the world’s first non-invasive therapeutic alternative for patients with severe symptomatic aortic stenosis. The degenerative condition is rapidly increasing due to population aging, and many patients still lack viable treatment options.
Carine Schorochoff, Chief Executive Officer and Board Director at Cardiawave, said the authorization represents a major milestone for the company and for patients. “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 non-invasive ultrasound therapy for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement, or refusing such intervention,” she said. “With CE Marking of our Valvosoft system, we can now provide a much-needed treatment option for patients.”
The approval follows data from the Valvosoft First-in-Man Study (24 months) and Valvosoft Pivotal Study (12 months), which evaluated the therapy in 100 elderly patients with significant comorbidities at 12 European centers across four countries. The studies demonstrated feasibility, safety, and meaningful clinical benefits. One year after treatment, patients showed sustained improvements in cardiac function and quality of life.
Prof. Christian Spaulding, Director of Interventional Cardiology at Hôpital Européen Georges Pompidou in Paris and Coordinating Investigator for the Valvosoft Pivotal Study, said the therapy offers new hope. “The Valvosoft Pivotal Study has demonstrated a strong safety profile and has shown its ability to improve hemodynamic 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,” he said.
Jonathan Freeman, Chairman of Cardiawave’s Board of Directors, said the approval underscores the advancement of therapeutic ultrasound. “Valvosoft perfectly illustrates how ultrasound technology is now coming of age, both from a regulatory standpoint and in terms of patient access. The CE Marking validates the robustness of this non-invasive approach and paves the way for broader adoption in Europe and beyond. This major milestone introduces a new therapeutic option that could transform the treatment of aortic stenosis and, more broadly, cardiovascular diseases,” he said.
Experts from North America also praised the development. Professors Josep Rodes-Cabau and Philippe Pibarot of Laval University said Valvosoft represents one of the most promising innovations in aortic stenosis in the past decade. “Its CE Marking is a major achievement, supported by robust clinical data showing safety, feasibility, and substantial clinical improvement in elderly patients with severe aortic stenosis,” they said. “A non-invasive therapy capable of improving valve function would represent a paradigm shift in how we manage aortic stenosis.”
Dr. Philippe Généreux, Director of the Structural Heart Program at the Gagnon Cardiovascular Institute in Morristown, New Jersey, said the milestone may signal a shift in the field. “The CE Marking of Valvosoft confirms the clinical value of the approach: using therapeutic ultrasound to treat aortic stenosis in a non-invasive way. This important milestone is exciting and potentially marks the beginning of a new era in the management of valvular disease,” he said.
Prof. Azeem Latib of Montefiore Health System in New York said the therapy could be especially impactful as more patients develop aortic stenosis with age. “Given the growing burden of aortic stenosis, and the clear clinical benefit of intervening before irreversible cardiac damage occurs, Valvosoft introduces a novel and highly promising therapeutic approach that could redefine how we manage this disease,” he said.
Valvosoft holds CE Marking in the European Union and remains investigational in all other regions, including the United States.
