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

Descrizione del progetto

Una nuova procedura di impianto della valvola tricuspide

La valvola tricuspide si trova tra le due camere destre del cuore e permette al sangue di fluire in modo unidirezionale dall’atrio al ventricolo. Il trattamento del malfunzionamento della valvola tricuspide prevede principalmente un intervento chirurgico a cuore aperto, poiché la sostituzione transcatetere della valvola è inefficiente e presenta molti potenziali effetti collaterali. Il progetto TriSol System, finanziato dall’UE, ha sviluppato una procedura di impianto rapida e minimamente invasiva che facilita il posizionamento di una nuova valvola in modo sicuro. L’approccio impiega un sistema di rilascio flessibile e i pazienti necessitano di un ricovero ospedaliero e un tempo di recupero minimi. Soprattutto, riduce gli elevati tassi di mortalità e i significativi effetti collaterali della chirurgia a cuore aperto.

Obiettivo

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.

Invito a presentare proposte

H2020-EIC-SMEInst-2018-2020

Vedi altri progetti per questo bando

Bando secondario

H2020-SMEInst-2018-2020-1

Meccanismo di finanziamento

SME-1 - SME instrument phase 1

Coordinatore

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

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PMI

L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.

Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Collegamenti
Costo totale
€ 71 429,00