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Cardiawave announces the success of its clinical trial to treat aortic stenosis

  • be safe and feasible
  • provide a sustained repair of the aortic valve
  • improve quality of life of the 34 patients treated

Paris, France, March 14, 2022 – Cardiawave SA, a deeptech medical device company that has developed VALVOSOFT® a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, today announced the success of its First-In-Human I (FIH I) safety and feasibility clinical trial.

VALVOSOFT® is a breakthrough technology that allows for the remote application of an extremely precise and focused therapeutic ultrasound beam to restore valve function in patients with aortic stenosis.
This intense beam decreases the stiffness of the aortic valve and improves its functional opening to allow sufficient oxygenated blood to reach the brain and the rest of the body. This non-invasive therapy is a new treatment option for aortic stenosis, as the only current medical response is to replace the aortic valve with open heart surgery, or with a minimally invasive percutaneous valve (TAVI) for the most severely affected
patients. Aortic stenosis has become a public health issue. This pathology affects between 2 and 12% of subjects over 65 years old (1.3 million patients in Europe).

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