Prospective, single-arm clinical investigation for the safety and feasibility study of Valvosoft Non-Invasive Ultrasound Therapy (NIUT) in patients with severe symptomatic aortic valve stenosis

Cardiawave (France) has developed a Non-Invasive Ultrasound Therapy (NIUT) for the treatment of cardio-valvular diseases such as aortic stenosis. This is the primary valve disease in adults and one of the leading causes of cardiovascular death worldwide which affects 10 million people in Europe and the USA.

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.

The results of the study are very promising. Analysis of the patients’ heart condition by echocardiography performed by an independent core laboratory, and of the clinical results at 6 months, confirms that this procedure is safe and can improve the condition of the heart and the clinical status of these very sick patients. For them, this new therapy can be a major therapeutic opportunity given the absence of other solutions.

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.

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Notes to editors

Key information

o A PCR Press Release on Prospective, single-arm clinical investigation for the safety and feasibility study of Valvosoft Non-Invasive Ultrasound Therapy (NIUT) in patients with severe symptomatic aortic valve stenosis – First-in-man by Sander Ijsselmuiden
o Presentation during the #PCR e-Course – http://www.pcr-ecourse.com

o Session on Hotline and Innovation Channel, Thursday 25 June – 17:06 Paris time (UTC+2)

o PCR e-Course: 25, 26, 27 June 2020

About PCR

The mission of PCR is to serve the needs of each individual patient by helping the cardiovascular community to share knowledge, experience and practice. PCR offers a wide range of other educational meetings and resources for the continuing education of the interventional cardiovascular community. These include major annual Courses across the globe, e-Learning with high-profile PCR Webinars, Courses specifically dedicated to valvular heart disease, tailor-made PCR Seminars on specific topics, online resources and medical publications such as EuroIntervention, the official journal of the EAPCI.

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For further information, please contact Célia Vilà: [email protected]