A new Non-Invasive Ultrasound Therapy (NIUT) for the treatment of cardio-valvular diseases such as aortic stenosis has been developed by Cardiawave (France).
A First-in-Man clinical trial in 10 patients to validate Cardiawave's innovative medical technology (labelled as the Valvosoft device) was conducted in Hôpital Européen Georges-Pompidou, Paris, France and in the Amphia Hospital, Breda, the Netherlands. These patients were not suitable for transcatheter aortic valve replacement (TAVR) or open-heart surgery, mainly due to the presence of concomitant diseases or problems to obtain access to the blood vessels with a catheter. Therefore, like 16% of people affected by severe symptomatic aortic stenosis (1.3 million people in Europe), they were left without alternative treatment.
The mechanism of this groundbreaking technology developed by Cardiawave consists in widening the opening of the aortic valve by delivering short sequences of high intensity ultrasounds, focused directly onto the valve from outside the body, thus eliminating the need for invasive treatment.
In the near future, this therapy might be used for other indications, such as to improve patients' condition and prepare them for TAVR (bridge to TAVR) and for less sick patients (severe asymptomatic and moderate aortic stenosis) to slow down the progression of their disease and delay the moment they need replacement of their valves.
This therapy can be done ambulatory and can be very cost-effective. In addition, as it is non-invasive, it most probably can be repeated to further improve or maintain its effect.
This work is supported by the French Government, managed by the National Research Agency (ANR) under the program "Investissements d'Avenir" with the references ANR-16-RHUS-0003_STOP-AS and ANR-17-CE 19-00 19-03 and has received funding from the European Union's Horizon 2020 research and innovation programme under accreditation n° 829492.