Embolic Protection Device for Heart Valve Implants

Transcatheter aortic valve implantation (TAVI) offers a minimally invasive alternative to the open heart AVR and is performed without the chest being opened or the need of a heart lung machine. However, TAVI has been reported to have an intra-operative stroke rate as high as 22%, which is five times higher than AVR. This constitutes a critical barrier that prevents the adoption of TAVI as a standard of care. Hence TAVI is currently reserved only for high-risk patients who would not tolerate AVR. As a part of the present project, the Embolisher is being developed as embolic deflector that prevents embolic debris from entering the brain vessels, and thus preventing any neurological dysfunction such as stroke. The device will be introduced temporarily into the aortic arch before commencement of TAVI and removed at the end of the procedure. The device is introduced via trans-femoral route, similar to a TAVI, and remains completely detached from the outside environment during operation. Once TAVI is complete, The Embolisher is retrieved by means of a novel retrieval mechanism, which is also part of the present innovation.