Periodic Reporting for period 2 - CAPTIS (An Embolic Protection Device for stroke prevention during heart valve replacement.)
Periodo di rendicontazione: 2020-09-01 al 2021-08-31
About 20 million people in the worldwide suffer from Aortic Stenosis, the most common and most severe heart valve disease. These patients commonly undergo a valve replacement treatment through Transcatheter Aortic Valve Implantation (TAVI). A major complication of TAVI is the release of embolic debris particles to the blood stream; particles migration to the brain or peripheral organs can cause life-threatening diseases such as stroke, acute kidney injury and ischemia. Embolic Protection Devices (EPDs) have been developed to counteract the risk of this major TAVI complication. However, currently available EPDs have limited efficacy, and therefore are poorly adopted, due to limited protection coverage (only brain and not peripheral organs), interaction with the TAVI delivery systems, and the need for a secondary access to the body, which further increases TAVI procedure duration and the risks connected to it.
Filterlex has developed the CAPTIS® Embolic Protection System, a next-generation, full-body embolic protection device, easily and intuitively deployed and retrieved. The device is securely positioned in the aorta, protects its surface while facilitating a seamless TAVI procedure. Its distinctive, triple action design provides for the first time a full-body embolic protection by deflecting, capturing and removing embolic particles. Uniquely, it requires no additional access and does not interfere to the procedure workflow.
The objectives of the proposed project include finalization of device safety assessment through animal studies, and validation of CAPTIS safety a performance in human studies to pursue CE Marking.
Filterlex has developed the CAPTIS® Embolic Protection System, a next-generation, full-body embolic protection device, easily and intuitively deployed and retrieved. The device is securely positioned in the aorta, protects its surface while facilitating a seamless TAVI procedure. Its distinctive, triple action design provides for the first time a full-body embolic protection by deflecting, capturing and removing embolic particles. Uniquely, it requires no additional access and does not interfere to the procedure workflow.
The objectives of the proposed project include finalization of device safety assessment through animal studies, and validation of CAPTIS safety a performance in human studies to pursue CE Marking.
Within the project, Filterlex has been actively working on validating CAPTIS safety through extensive animal testing for obtaining Ethics Committees approval for the foreseen clinical trials. The system was presented in several conferences and events, enabling Filterlex to strengthen their network of Key Opinion Leaders.
Filterlex aim to demonstrate safety and efficacy of the CAPTIS system in a clinical trial in selected hospitals across Europe and Israel, and collect the clinical evidence required for CE Mark certification and market launch. The SME Instrument Phase II project will enable to release the CAPTIS® Embolic Protection System into the European marketplace and provide a unique solution to reduce the vast societal and economic burden of TAVI complications.