Cardiawave has received CE certification for Valvosoft, its non-invasive therapeutic alternative to treat severe symptomatic aortic stenosis.
Valvosoft 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.
“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 (NIUT) for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement, or refusing such intervention,” said Carine Schorochoff, chief executive officer and board director at Cardiawave. “With CE marking of our Valvosoft system, we can now provide a much-needed treatment option for patients.”
This approval follows the results from Cardiawave’s Valvosoft first-in-man (FIM) study (24 months) and Valvosoft pivotal study (12 months) evaluating its innovative therapy for the treatment of severe symptomatic aortic stenosis. Conducted in 100 elderly, highly comorbid patients across 12 European centres in four countries, the studies demonstrated the feasibility, safety, and clinical benefits of the therapy, the company says in a press release. Durable improvements were observed one year after treatment, including enhanced cardiac function and significantly better patient quality of life.
Christian Spaulding (Hôpital Européen Georges Pompidou AP-HP, Paris, France) coordinating investigator for the Valvosoft pivotal study, stated: “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.”
“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,” said Jonathan Freeman, chairman of the board of directors.
“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,” comments Philippe Généreux (Morristown Medical Center, Morristown, USA).
