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 (CAS), an investigational device. CAS 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 in the Netherlands to enrol 10 patients. Another 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. These studies are still ongoing (FIH-I inclusion being completed). A Research Letter presenting the preliminary clinical results of the first 10-patients included in FIH-I has been published in Circulation on January 25, 2021.