PARIS– Cardiawave SA, a deeptech medical device manufacturer that has developed VALVOSOFT® a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, today announced positive MRI scans before and after therapeutic ultrasound treatment to assess the risk of stroke.
This final phase of the clinical study “VALVOSOFT® FIM STUDY” (FIM II) showed no signs of any cerebral vascular anomaly in the 10 patients treated. This marks the completion of two successful First-In-Human clinical studies involving a total of 40 patients treated in France, the Netherlands and Serbia.
“This confirmation of the safety of VALVOSOFT® bodes well for the launch of patient recruitment for our European pivotal study which will commence shortly in France, and extended to Germany and the Netherlands, with the aim of obtaining CE Marking.” said Benjamin Bertrand, CEO of Cardiawave.
VALVOSOFT®’s non-invasive treatment brings great hope for patients with aortic stenosis and for their families. Having the absence of any abnormality before and after treatment being confirmed by MRI scans is major clinical step forward” declared Professeur Emmanuel Messas the Georges Pompidou European Hospital (AP-HP), in Paris.
