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

Informations projet

Filterlex

N° de convention de subvention: 832211

DOI

10.3030/832211

Projet clôturé

Date de signature de la CE 23 Novembre 2018

Date de début 1 Novembre 2018

Date de fin 28 Février 2019

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

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.)

Période du rapport: 2018-11-01 au 2019-02-28

Résumé du contexte et des objectifs généraux du projet

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.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

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.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

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.

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