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

Projektinformationen

CAPTIS

ID Finanzhilfevereinbarung: 881076

DOI

10.3030/881076

Projekt abgeschlossen

EK-Unterschriftsdatum 30 August 2019

Startdatum 1 September 2019

Enddatum 31 August 2021

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 3 050 000,00

EU-Beitrag

€ 2 135 000,00

Koordiniert durch

FILTERLEX MEDICAL LTD
Israel

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

Berichtszeitraum: 2020-09-01 bis 2021-08-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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.

publishable-image.png