CARDIAWAVE

With a quality management system, EN ISO 13485:2016 certified since 2019, Cardiawave has developed a non-invasive ultrasound therapy (NIUT) medical device for the treatment of calcific Aortic Stenosis (AS), an investigational device. Calcific AS is the most prevalent heart valve disease in adults and one of the most common causes of cardiovascular mortality worldwide. Early 2019, Cardiawave was granted approval to perform a first-in-human feasibility and safety clinical study (FIH‑I) in France and the Netherlands to enrol 10 patients. A second study (FIH-II) has been approved in Serbia and started at the end of 2019. In 2020, Cardiawave obtained approval for an extension of its FIH-I, increasing the study population up to 30 patients. First results of the data up to 6 months follow-up of both studies have been published in The Lancet ⁽¹⁾.
In June 2022, following the positive preliminary results of our FIH clinical studies, Cardiawave started a pivotal confirmatory study on severe symptomatic aortic valve stenosis patients who were for immediate aortic valve replacement or refused such an intervention (note: last indication not approved in France by ANSM).
In July 2023, Cardiawave successfully enrolled 60 patients in 11 clinical sites in France, Germany and the Netherlands and marks a significant milestone in the development of Cardiawave’s medical advances, paving the way for CE marking of the device. The 6 months results were presented at the TCT 2024 in Washington DC by Professor Hélène Eltchaninoff.