Cardiawave SA is the developer of the Valvosoft Non-Invasive Ultrasound Therapy (NIUT) device for the treatment of severe symptomatic calcific aortic stenosis (CAS). The company tells us it met the primary endpoint in its pivotal study and improved or stabilized heart failure symptoms for 80.5% of patients. Investigators reported substantially improved hemodynamics and patient quality of life six months after treatment.
Valvosoft Background
Based near Paris, Cardiawave’s Valvosoft is a Non-Invasive Ultrasound Therapy (NIUT) medical device for the treatment of valvular heart diseases. The company’s initial focus is on calcific aortic stenosis (CAS). This is the most prevalent heart valve disease in adults. Tellingly the subject crops up all too frequently on our pages. Moreover it’s one of the most common causes of cardiovascular mortality worldwide. The proprietary NIUT technology combines therapeutic ultrasound, robotics and ultrasound imaging.
Valvosoft’s design means it can 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. Usefully the treatment is designed to be repeatable over time, as needed, to manage disease progression.
Valvosoft Pivotal Study 6 Month Results
The Valvosoft Pivotal Study is a prospective, multicenter, single-arm study encompassing 60 patients with severe symptomatic CAS treated with Valvosoft NIUT at 11 European centers.
In the study, 91.7% of patients were free of Major Adverse Cardiac Events (MACE) at 30 days. This far exceeds the primary endpoint objective of <25%. Furthermore there were no incidences of stroke through six months. Additionally Valvosoft demonstrated the ability to reverse or slow disease progression. At six months, compared to baseline 80.5% of patients saw improved or stabilized New York Heart Association (NYHA) class. Quality of life also consistently improved over that time. Indeed patients showing an average Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of 8.7 points over baseline.
In fact patient hemodynamics also improved. Aortic Valve Area (AVA) increased by 12% over baseline by six months post-procedure. Remarkably this is in a patient population where 40% of patients were classified with very severe aortic stenosis. Furthermore 31% were 90 or older. Although the study did not include a control group, when the AVA measures were compared to the expected AVA among untreated patients based on natural disease progression [1], the AVA improvement was shown to be 21.4%. The mean pressure gradient decreased by 6% compared to baseline at six months. In additions, when compared to natural disease progression [1], that improvement reached -13.2%.
Investigator comments
Professor Christian Spaulding, is an Interventional Cardiologist, Professor of Cardiology at European Hospital Georges Pompidou AP-HP in Paris, France. As a coordinating investigator of the Valvosoft Pivotal Study he commented about the findings.
“The Valvosoft Pivotal Study demonstrated the ability of this novel ultrasound therapy to improve patient hemodynamics and quality of life entirely non-invasively. This therapy has the potential to offer a paradigm shift in the lifetime management of aortic stenosis.”
“Aortic stenosis is progressive and threatens the lives of many millions of people each year. With the disease on the rise due to a rapidly aging population, clinicians need new alternatives for patients who cannot or do not want to undergo current valve replacement techniques. The Valvosoft technology holds the possibility to be an important and unique addition to our armamentarium to address progression of this deadly disease.”
Company comments
Cardiawave’s management team issued their own comments as follows.
“We would like to thank all study investigators for their continuous support, dedication and tireless efforts. This important technology has the potential to transform the lifetime management of aortic stenosis.
“We are gratified by the positive six-month results. Furthermore early signs from one-year clinical results across all patients provide further encouragement. We expect these data will validate and even exceed them. This clinical study is taking us one more step forward in our journey of bringing non-invasive heart valve therapy to patients and healthcare institutions around the world. We remain focused on obtaining regulatory approvals in the European Union and in the U.S. for Valvosoft. We anticipate market entry in Europe next year.”
Valvosoft is an investigational device in the U.S. and is limited by U.S. law to investigational use only. It is not approved for commercial sale in any region.
[1] G. Prosperi-Porta, N. Willner, and D. Messika-Zeitoun, “Aortic stenosis progression: Still a long way to go,” Arch Cardiovasc Dis, vol. 116, no. 3, pp. 113–116, Mar. 2023, doi: 10.1016/j.acvd.2023.01.002.
published: November 5, 2024 in: Cardio, Clinical Studies/Trials, Congresses and Meetings, Regulatory, Technology
