Filterlex is a unique, full-body, embolic protection device for Trans-catheter Aortic Valve Implantation procedures.

Información del proyecto

Filterlex

Identificador del acuerdo de subvención: 832211

DOI

10.3030/832211

Proyecto cerrado

Fecha de la firma de la CE 23 Noviembre 2018

Fecha de inicio 1 Noviembre 2018

Fecha de finalización 28 Febrero 2019

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

FILTERLEX MEDICAL LTD
Israel

Periodic Reporting for period 1 - Filterlex (Filterlex is a unique, full-body, embolic protection device for Trans-catheter Aortic Valve Implantation procedures.)

Período documentado: 2018-11-01 hasta 2019-02-28

Resumen del contexto y de los objetivos generales del proyecto

Filterlex Medical Ltd is a med-tech company with the vision is to provide the best-in-class embolic protection device (EPD) for reducing the risk of stroke and other complications during catheter-based left-heart procedures. The CAPTIS® concept and unique structure was created out of deep understanding and knowledge of the unmet need and product limitations of current solutions available on the market. The company’s mission is to make TAVI procedure safe to increase treatment options for high-risk patients who need heart valve procedures.

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

Throughout the duration of the project, Filterlex defined the preliminary updates of the CAPTIS® system, reviewed its development plan, supply chain, and scouted for third parties to support in the development stage and the distribution channels. The market segments and opportunities have also been evaluated, defining the TAM and SAM. A commercialisation strategy has been established. The Phase 1 feasibility assessment has determined that a development plan for the CAPTIS® system is technically and commercially viable, and that further engineering, manufacturing and commercialisation plan should be pursued. The SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully.

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)

In the current economic climate, European healthcare systems face challenges to reduce the healthcare expenditure in an effort to reduce public sector deficits while maintaining quality. Approximately 17 million people in Europe and over 8 million people in the US suffer from heart valve diseases, 43% of which suffers from Aortic Stenosis (AS). The aging of the population worldwide will result in increasing numbers of elderly patients, among whom heart disease is the leading cause of death. For AS patients the most common treatment is valve replacement through Transcatheter Aortic Valve Implantation (TAVI). During TAVI, embolic debris are generated from the natural aortic valve area and from the passage of large-calibre catheters through a diseased and calcified aortic arch. If not properly removed, these debris are released into the vascular system, reaching and damaging the brain or other organs by reducing or blocking blood flow. The CAPTIS® system is a novel intra-aortic Embolic Protection Device (EPD) for deflecting, capturing and removing embolic particles during TAVI procedure.

filterlex-01407-1.png