An Embolic Protection Device for stroke prevention during heart valve replacement.

ended

Aortic stenosis (AS) is the most common and most severe heart valve disease, affecting 20 million people worldwide. For patients with severe AS, the most common treatment is valve replacement through Transcatheter Aortic Valve Implantation (TAVI). The procedure is very risky, since embolic debris are released to the blood stream and may reach the brain and other organs, reducing or blocking the blood flow. Strikingly, embolic debris cause new ischemic brain lesions in 70% of patients post TAVI, major disabling strokes in 9%, and kidney dysfunction 12.3% of cases. Embolic Protection Devices (EPDs) are being developed to reduce the risk posed by embolic debris during TAVI. To date, only one EPD has been commercialised for use in TAVI procedure. Unfortunately, the device is poorly effective since it can only provide partial cerebral protection, interferes with the TAVI delivery system, and requires secondary artery access to the TAVI system, thus increasing procedure time and posing the patient at a higher risk of post-operative side effects. Filterlex developed the CAPTIS® system, an innovative intra-aortic Embolic Protection Device (EPD) for deflecting, capturing and removing embolic particles during TAVI procedure. Easily positioned, deployed and retrieved through the same TAVI artery access, this revolutionary EPD provides full-body protection by ensuring the best performance in capturing and safely removing the embolic debris released during TAVI. In this way, CAPTIS strongly reduces the risk of stroke and ischemia to other vital organs. The key objectives of the project are to validate safety and efficacy of the CAPTIS system through a First-In-Human clinical trial and multi-site clinical trial, and to obtain CE mark certification for commercialisation in Europe.