Cardiawave SA, the developer of the innovative Valvosoft Non-Invasive Ultrasound Therapy (NIUT) device for severe symptomatic calcific aortic stenosis (CAS), announced today that the device achieved its primary endpoint in a pivotal study. Six months post-treatment, 80.5% of patients experienced improved or stabilized heart failure symptoms, along with significant enhancements in hemodynamics and quality of life. These results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference by Professor Hélène Eltchaninoff, Head of the Cardiology Department at Rouen University Hospital, France.
Valvosoft: A Breakthrough in Non-Invasive Treatment for Aortic Stenosis
Valvosoft is designed to non-invasively restore mobility in the leaflets of a stenotic aortic valve, widening the valve opening to alleviate heart failure symptoms. The device employs high-intensity focused ultrasound to micro-fracture calcifications within the valve leaflets without harming surrounding tissue. This treatment is intended to be repeatable over time, allowing for effective management of disease progression.
“The Valvosoft Pivotal Study showcased this innovative ultrasound therapy’s ability to enhance patient hemodynamics and quality of life entirely non-invasively. This could revolutionize the long-term management of aortic stenosis,” said Professor Christian Spaulding, an interventional cardiologist at European Hospital Georges Pompidou AP-HP in Paris and the coordinating investigator for the study. “Aortic stenosis is progressive and threatens millions of lives each year. As the disease prevalence rises due to an aging population, new options are essential for patients who cannot or prefer not to undergo traditional valve replacement procedures. Valvosoft may provide a crucial and unique tool in combating this serious condition.”
Valvosoft Pivotal Study Six-Month Results
In the study, 91.7% of participants were free of Major Adverse Cardiac Events (MACE) at 30 days, surpassing the primary endpoint goal of <25%. No strokes occurred over the six-month period. Valvosoft effectively reversed or slowed disease progression, with 80.5% of patients showing improved or stabilized New York Heart Association (NYHA) class compared to baseline. Quality of life also significantly improved, with an average increase of 8.7 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Patient hemodynamics saw notable improvements as well. The Aortic Valve Area (AVA) increased by 12% from baseline six months post-procedure, with 40% of patients classified as having very severe aortic stenosis and 31% aged 90 or older. While there was no control group, when comparing AVA improvements to expected values among untreated patients based on natural disease progression, the increase was 21.4%. Additionally, the mean pressure gradient decreased by 6% compared to baseline; this improved to -13.2% when considering natural disease progression.
The Valvosoft Pivotal Study is a prospective, multicenter, single-arm study involving 60 patients with severe symptomatic CAS treated at 11 European centers.
“We extend our gratitude to all study investigators for their unwavering support and commitment to this important technology, which has the potential to transform the management of aortic stenosis,” said Cardiawave’s management team. “We are encouraged by the positive six-month results and optimistic about our early look at one-year clinical outcomes, which we believe will further validate these findings. This study marks a significant step in our mission to provide non-invasive heart valve therapy to patients worldwide. We remain focused on securing regulatory approvals in the European Union and the U.S. for Valvosoft, anticipating market entry in Europe next year.”
Valvosoft is classified as an investigational device in the U.S. and is limited to investigational use only. It is not approved for commercial sale in any region.
About Cardiawave
Based near Paris, Cardiawave has developed a Non-Invasive Ultrasound Therapy (NIUT) medical device aimed at treating valvular heart diseases, particularly calcific aortic stenosis (CAS), which is the most common heart valve disease in adults and a leading cause of cardiovascular mortality worldwide. The proprietary NIUT technology integrates therapeutic ultrasound, robotics, and ultrasound imaging.
