Image: Patient affected by severe symptomatic aortic stenosis treated with Valvosoft (Photo courtesy of Amphia Ziekenhuis)
Aortic stenosis is a degenerative and potentially life-threatening condition, caused by calcium build-up which prevents the aortic valve from fully opening, leading to heart failure. The only current medical response is to replace the aortic valve with open heart surgery, or with a minimally invasive percutaneous valve (TAVI). Now, a new non-invasive treatment combining therapeutic ultrasound, robotics and ultrasound imaging brings great hope for patients with aortic stenosis and for their families.
Cardiawave SA (Paris, France) has developed VALVOSOFT, a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults. 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.
Cardiawave has also announced the success of its First-In-Human I (FIH I) clinical trial to assess the safety, and operating system of the first generation of VALVOSOFT as well as the clinical effects of softening calcific aortic valve tissues with a beating heart. 30 patients (average age 84 years, with nine patients aged over 90 years) have been successfully treated. VALVOSOFT provided a sustained repair to the aortic vavlve for up to 12 months post treatment. The study has proven the safety and efficacy, as well as the ease of the procedure with a 60 minute non-invasive outpatient treatment. Following the successful VALVOSOFT treatment, two patients were able to have TAVI valve replacement.
VALVOSOFT non-invasive treatment offers the possibility of an efficient outpatient treatment for fragile patients, for whom valve replacement is too risky. In the longer term, treating patients with less severe stenosis would be a major step forward. A second feasibility and safety FIH II study is underway with 10 further patients. This includes brain MRI evaluation both before and after treatment to assess the risk of a stroke. Four patients were safely treated by the end of December 2021. None of the MRIs detected an abnormality. Six further patients will be treated during H1 2022.
“The positive results of the safety and feasibility clinical studies we observed in our First In Human trial are extremely encouraging. We have shown that VALVOSOFT can treat patients who are exceedingly fragile and sick for whom no medical solution exists today. This represents a new treatment solution for aortic stenosis, over and above aortic valve replacement from which only a small minority of patients can benefit. Cardiawave’s VALVOSOFT has the potential to become a standard new treatment for this deadly disease," said Benjamin Bertrand, CEO of Cardiawave. "We are currently working on receiving the necessary authorizations in Europe for further clinical trials over the next few months. I am confident that these will once again confirm the therapeutic benefits of VALVOSOFT.”