Cardiawave’s Valvosoft Pivotal Study 6-Month Follow-Up Data Presented

November 11, 2024—Cardiawave SA, developer of the Valvosoft noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic calcific aortic stenosis, recently announced that the device met the primary endpoint in its pivotal study and improved or stabilized heart failure symptoms for 80.5% of patients, substantially improving hemodynamics and patient quality of life 6 months after treatment.

According to the company, the VALVOSOFT pivotal study is a prospective, multicenter, single-arm study encompassing 60 patients with severe symptomatic calcific aortic stenosis treated with Valvosoft NIUT at 11 European centers.

Cardiawave also advised that 12-month follow-up for the VALVOSOFT pivotal study has been completed and the 1-year results are expected to be published in early 2025.

Professor Hélène Eltchaninoff, MD, Head of the Cardiology Department at Rouen University Hospital in Rouen, France, presented the 6-month outcomes at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

The company reported that in the study, 91.7% of patients were free of major adverse cardiac events at 30 days, which achieved the primary endpoint objective of <25%.

As summarized in Cardiawave’s press release, the 6-month findings showed the following:

• There were no incidences of stroke.
• Valvosoft reversed or slowed disease progression, improving or stabilizing New York Heart Association class for 80.5% of patients compared to baseline.
• Quality of life consistently improved with patients showing an average Kansas City Cardiomyopathy Questionnaire score improvement of 8.7 points over baseline.
• Hemodynamics improvement was shown by aortic valve area (AVA) increased by 12% over baseline, in a patient population where 40% of patients were classified with very severe aortic stenosis and 31% were age ≥90 years.

The company further noted that 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, the AVA improvement was shown to be 21.4%. The mean pressure gradient decreased by 6% compared to baseline at 6 months. When compared to natural disease progression, that improvement reached -13.2%.

Cardiawave stated that Valvosoft device is designed to noninvasively restore leaflet mobility in a stenotic aortic valve and widen the valve opening to relieve heart failure symptoms. High-intensity focused ultrasound waves microfracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.

Professor Christian Spaulding, MD, is coordinating investigator of the VALVOSOFT pivotal study. Prof. Spaulding is an interventional cardiologist and Professor of Cardiology at European Hospital Georges Pompidou AP-HP in Paris, France.

“The VALVOSOFT pivotal study demonstrated the ability of this novel ultrasound therapy to improve patient hemodynamics and quality of life entirely noninvasively,” commented Prof. Spaulding in Cardiawave’s press release. “This therapy has the potential to offer a paradigm shift in the lifetime management of aortic stenosis.”

Prof. Spaulding continued, “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, new alternatives are needed 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.”

Valvosoft is an investigational device in the United States and is limited by law to investigational use only. It is not approved for commercial sale in any region, advised Cardiawave.