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

Información del proyecto

CAPTIS

Identificador del acuerdo de subvención: 881076

DOI

10.3030/881076

Proyecto cerrado

Fecha de la firma de la CE 30 Agosto 2019

Fecha de inicio 1 Septiembre 2019

Fecha de finalización 31 Agosto 2021

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 3 050 000,00

Aportación de la UE

€ 2 135 000,00

Coordinado por

FILTERLEX MEDICAL LTD
Israel

Periodic Reporting for period 2 - CAPTIS (An Embolic Protection Device for stroke prevention during heart valve replacement.)

Período documentado: 2020-09-01 hasta 2021-08-31

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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.

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