Cardiawave wins CE mark for non-invasive aortic stenosis treatment

Cardiawave announced that it received CE mark approval for Valvosoft, its non-invasive therapeutic alternative for treating aortic stenosis (AS).

Valvosoft utilizes non-invasive ultrasound therapy (NIUT) to treat severe symptomatic aortic stenosis (sSAS). France-based Cardiawave says its therapy is the first non-invasive therapeutic alternative for sSAS, which is commonly treated with transcatheter aortic valve replacement (TAVR).

The company designed its platform to non-invasively restore leaflet mobility in a stenotic aortic valve. It widens the valve opening to relieve the patient’s heart failure symptoms. High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue.

Sign up for Blog Updates