Key Points
- Cardiawave SA announced that its Valvosoft® device has been granted authorization in Europe to address severe symptomatic aortic stenosis.
- The ruling was based on positive clinical results from 100 participants treated across 12 European centers.
French medtech company Cardiawave SA recently announced that its Valvosoft® device has been granted CE Marking in Europe for the treatment of severe symptomatic aortic stenosis. The device delivers focused ultrasound to calcified aortic valves to nonthermally soften the valve leaflets and improve valve function. It is guided under real-time ultrasound imaging.
The approval was based on positive results from studies (NCT04665596, NCT03779620, NCT05235568) that treated 100 elderly, highly comorbid participants across 12 European centers in 4 countries. The studies demonstrated the feasibility, safety, and clinical benefits of the therapy, and the results remained durable at least one year after treatment.
“Innovating to address unmet patient needs is at the heart of Cardiawave’s mission,” said Carine Schorochoff, chief executive officer and board director at Cardiawave, in the company’s release. “We are therefore extremely proud to have received the CE Certificate for our first-of-its-kind noninvasive ultrasound therapy for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement or refusing such intervention. With CE Marking of our Valvosoft system, we can now provide a much-needed treatment option for patients.”
Read Cardiawave’s Press Release
Related Stories
Aortic Valve Stenosis Clinical Trial Data Reported in The Lancet November 2023
Study Suggests Focused Ultrasound Treatment of Aortic Valve Stenosis Safe, Stroke-Free July 2023