Cardiawave said its device for the treatment of severe symptomatic calcific aortic stenosis (CAS) met the primary endpoint in a pivotal study. The investigational Valvosoft non-invasive ultrasound therapy (NIUT) device improved or stabilized heart failure symptoms for 80.5% of patients. It substantially improved hemodynamics and patient quality of life six months after treatment, according to a news release. Dr. Hélène Eltchaninoff presented findings from the study at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.

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Cardiawave designed Valvosoft to non-invasively restore leaflet mobility in a stenotic aortic valve. It widens 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 company said it designed the treatment for repeatability over time, as needed, to manage disease progression.

Cardiawave’s study evaluated 60 patients with severe symptomatic CAS treated with Valvosoft NIUT at 11 European centers.

In the study, 91.7% of patients registered as free of major adverse cardiac events (MACE) at 30 days. Investigators reported zero incidences of stroke through six months. Valvosoft demonstrated the ability to reverse or slow disease progression, improving or stabilizing New York Heart Association (NYHA) class for 80.5% of patients compared to baseline at six months.

Investigators reported consistent quality of life improvements over that time as well. Patients showed an average Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of 8.7 points over baseline.

Additionally, patient hemodyanmics improved, with aortic valve area (AVA) increasing by 12% over baseline by six months post-procedure.

“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,” said Cardiawave’s management team. “We remain focused on obtaining regulatory approvals in the European Union and in the U.S. for Valvosoft, and anticipate market entry in Europe next year.”