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Cardiawave obtains clinical trial authorization for the world' first non-invasive treatment solution for aortic stenosis

Press releases may be edited for formatting or style | April 03, 2019 Cardiology


There are two forms of treatment currently available for aortic stenosis: the Transcatheter Aortic Valve Replacement (TAVR) procedure and open-heart valve replacement surgery. However, these approaches are not suitable for all patients. Even though the development of the TAVR procedure has made treatment possible for some patients who are ineligible for aortic valve replacement surgery, it does not provide a solution for all patients as there is still some risk involved in this procedure. Simply put, elderly patients with multiple comorbidities may be deemed ineligible for surgery by the Heart Team.
As Professor Bernard Jung, cardiologist and specialist in valvular diseases at Bichat-Claude Bernard Hospital points out: "What we know for certain, is that between 10 and 20% of patients are not suitable for TAVR or surgery as the health risk outweighs the benefits. Many of these patients would therefore make excellent potential candidates for a palliative approach such as that of Cardiawave".

There are other advantages to the Cardiawave solution. As Prof. Emmanuel Messas explains: "The therapy that we have developed opens up new possibilities for patients who are currently awaiting treatment for this disease. We hope to improve the quality of life of these patients with this potentially ambulatory treatment. Lastly, in the not so distant future, we may be able to offer this treatment in a preventive capacity."

The clinical trials will determine whether the therapy developed by Cardiawave is effective and risk-free, or if further fine-tuning is required. Cardiawave will also be positioned as the new solution for aortic stenosis, a huge public health issue, for which the average age of onset is 65 years in Western countries, and where the number of cases is continuously on the rise.

Based at the business incubator of Paris Biotech Santé in Cochin and member of the national research consortium RHU STOP-AS, Cardiawave has developed a completely non-invasive medical device for the treatment of cardio-valvular diseases, in particular aortic stenosis, the primary valvopathy in adults and one of the leading causes of cardiovascular death worldwide. Member of the medical cluster MEDICEN, the company employs a staff of 20 and has secured over €14M in funding since its creation at the end of 2014.

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