Cardiawave obtains CE mark for therapy treating ultrasound aortic stenosis

French medical technology company Cardiawave has received the European CE mark for its Valvosoft system, a groundbreaking non-invasive ultrasound therapy (NIUT) designed for patients with heart valve disease. This approval makes Valvosoft the first device of its type accessible to individuals with severe symptomatic aortic stenosis (sSAS) who may not qualify for conventional treatments like transcatheter aortic valve replacement (TAVR).

The CE marking follows the successful completion of Cardiawaves initial human trials and pivotal studies. These studies confirmed the treatments safety, feasibility, and clinical effectiveness, showing sustained benefits one year post-treatment, including improved heart function and enhanced patient quality of life.

Valvosoft operates by delivering focused, high-intensity ultrasound pulses that soften and restore calcified aortic valves. Carine Schorochoff, CEO of Cardiawave, stated: Our mission is to address unmet patient needs. Receiving CE certification for our first-of-its-kind NIUT enables us to offer a vital option for patients with aortic valve stenosis who are unsuitable or unwilling to undergo immediate valve replacement. With this approval, we can now provide an essential therapeutic alternative.

The pivotal trial involved 100 elderly patients with multiple comorbidities across 12 sites in Europe. Professor Christian Spaulding, director of interventional cardiology at Hpital Europen Georges Pompidou in Paris and coordinating investigator of the study, commented: The Valvosoft trial demonstrated excellent safety and the ability to enhance haemodynamic parameters in patients with severe symptomatic aortic stenosis who cannot receive immediate valve replacement. The improvements in patient quality of life now offer treatment possibilities for those previously without options.

In sSAS, the narrowing of the aortic valve limits blood flow from the heart to the body. Although TAVR has become a popular treatment, studies indicate that up to 16% of patients may be ineligible due to factors such as age, health status, or anatomical considerations. Valvosoft provides a new therapeutic pathway for these patients.

Author: Gavin Porter