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A heart valve prosthesis and delivery system intended to replace damaged tricuspid valves and prevent right ventricle dysfunction

Description du projet

Une nouvelle procédure d’implantation de la valve tricuspide

La valve tricuspide se trouve entre les deux cavités droites du cœur et permet au sang de circuler de manière unidirectionnelle de l’oreillette au ventricule. Le traitement du dysfonctionnement de la valve tricuspide implique principalement une opération à cœur ouvert étant donné que le remplacement transcathéter d’une valve est inefficace et entraîne de nombreux effets secondaires potentiels. Le projet TriSol System, financé par l’UE, a développé une procédure d’implantation mini-invasive et rapide qui facilite le positionnement d’une nouvelle valve de manière sûre. Cette approche recourt à un système d’administration flexible, avec un temps minimal d’hospitalisation et de récupération des patients. Il réduit surtout les taux élevés de mortalité et les effets secondaires considérables d’une opération à cœur ouvert.

Objectif

About 17 million people die each year from cardiovascular diseases (CVDs), a number that is expected to grow to more than 23 million by 2030. Of these deaths, an estimated 7.4 million were due to heart disease, including heart valve disease (HVD) such as tricuspid regurgitation (TR). The golden standard methods for tricuspid valve diseases are standard open-heart surgery and transcatheter valve replacement. However, high-risk interventions require long recovery time long in-hospital stays and have significant hospital mortality (more than 10%). Transcatheter tricuspid valve replacement (TTVR) is still ineffective due to the increased risk of side effects in right ventricle making this solution not available on the market. TriSol is introducing the TriSol System, a heart valve replacement system for treating severe TR and preventing RV dysfunction which usually follows tricuspid valve surgery. A flexible delivery system allows to position the valve into the heart through support arms for anchoring to the tricuspid physiological site. The entire procedure is performed in a medical center and takes up to 30 minutes compared to 2-4 hours of standard surgery. Trisol System will allow cardiologists to perform a quick and safe implant procedure thus increasing the number of treated population and reducing in-hospital and recovery time. Moreover, it will increase heart performance and reduce the risk of mortality typical of open-heart surgeries.
During the feasibility assessment, a go-to-market strategy and a supply chain will be established, as well as further development plan will be drafted. During the second phase of innovation project, TriSol will upgrade the valve and delivery system components of TriSol system for application in multiple valve conditions such as mitral valve regurgitation. It will also increase the production line up to 4k per year. Multiple clinical trials will then be initiated for obtaining CE mark as a medical device.

Appel à propositions

H2020-EIC-SMEInst-2018-2020

Voir d’autres projets de cet appel

Sous appel

H2020-SMEInst-2018-2020-1

Régime de financement

SME-1 - SME instrument phase 1

Coordinateur

TRISOL MEDICAL LTD
Contribution nette de l'UE
€ 50 000,00
Adresse
TAVOR BUILDING ENTRANCE 2 LEVEL 3
2069202 YOKNEAM
Israël

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PME

L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.

Oui
Type d’activité
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Liens
Coût total
€ 71 429,00