Press release • Paris, 3 April 2019 • Cardiawave, the MedTech company created following research conducted by the Institut Langevin and the Georges Pompidou European Hospital, announces that it has obtained the authorization to launch clinical trials for its non-invasive treatment solution for aortic stenosis. This announcement highlights the need for a solution to this unmet medical need which affects millions of patients.
A GROUND-BREAKING NEW THERAPY FOR CALCIFIC AORTIC STENOSIS
Cardiawave has developed a highly innovative technology, non-invasive therapy to treat Calcific Aortic Stenosis. It improves the opening of heavily calcified aortic valves by reducing the stiffness in the aortic valve tissue using high-energy, short pulses of ultrasound that are transmitted directly into the aortic valve from outside the body.
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CLINICAL TRIALS: THE FIRST STEP TOWARDS A NEW TREATMENT FOR AORTIC STENOSIS
Authorization has now been granted by ethical committees and competent authorities (in France the Agency for the Safety of Medicines, ANSM) to begin clinical trials in France and the Netherlands, with imminent approval in Serbia as well. A trial in 10 patients will therefore commence shortly, with the patient inclusion process scheduled to end in the summer of this year.
This multi-center, international study is a collaborative project between three renowned centers: the Georges Pompidou European Hospital (HEGP) in Paris, France; the Amphia Hospital in Breda, the Netherlands; the Clinical Center of Serbia in Belgrade, Serbia. The trial will be coordinated by Professor Emmanuel Messas, cardiologist at the HEGP.
According to Benjamin Bertrand, CEO of Cardiawave: "The granting of these authorizations in several countries is recognition for the hard work of our teams and partners over the last few years, and it paves the way for a completely non-invasive treatment for this disease which affects an increasing number of patients due to an aging population. We are delighted to participate in this study in France, because the project has been predominantly funded and supported by French stakeholders in both public and private sectors".
In practical terms, the multi-disciplinary cardiovascular team (the "Heart Team") within these three investigative centers will initially determine the eligibility of patients and obtain their informed consent; a Case Review Committee will then confirm this eligibility and the patient can proceed to the treatment stage. By performing an echocardiogram before, during and after the therapy, the movements of the valve can be monitored and the affected areas can be precisely targeted with the therapeutic ultrasound pulses. Finally, a post-treatment evaluation will be scheduled at 1, 3, 6, 12 and 24 months to ensure patient safety and the efficacy of the therapy. A central laboratory (Cardialysis BV, Rotterdam, The Netherlands), acting in the capacity of an independent competent third-party, will objectively assess the condition of the patients' aortic valves at each time point.