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CORDIS

Minimally invasive suturing for vascular bore closure and heart defect repair

Descripción del proyecto

Dispositivo de cierre vascular de gran calibre más seguro

Los avances importantes de las tecnologías médicas han permitido desarrollar procedimientos transcatéter para sustituir a las intervenciones a corazón abierto. Estos procedimientos permiten mejorar los resultados clínicos, acortar las estancias hospitalarias y acelerar los tiempos de recuperación, pero requieren accesos vasculares grandes. El cierre de estos accesos grandes se asocia a una elevada tasa de complicaciones. El equipo del proyecto NVCD, financiado por el Consejo Europeo de Innovación, desarrollará una tecnología propia de microsutura para lograr un cierre vascular de gran calibre más eficaz y seguro. Tras el desarrollo del prototipo y su validación preclínica, el equipo del proyecto llevará a cabo ensayos clínicos para obtener la certificación CE que permita el despliegue comercial del dispositivo de sutura.

Objetivo

Cardiovascular diseases (CVDs) remain a major health problem worldwide and a leading cause of mortality, with over annual 18 million deaths. In Europe, CVDs are associated with 4 million deaths and costs of around 210 billion per year.
Many surgeries to treat cardiac conditions are shifting to be minimally invasive and this is a trend expected to continue growing due to its multiple advantages over open interventions. However, as newly developed devices for transcatheter procedures become bigger they also require larger vascular access sites. A couple of devices are used in vascular large-bore closure (e.g. ProGlide from Abbott). However, they are associated with still high vascular and bleeding complications (up to 20%, depending on the operators skills). Such complications are linked to longer hospitalizations, unnecessary suffering, and greater healthcare costs (20k per patient), as well as higher morbidity and mortality.
To solve this persistent unmet need in the field of cardiovascular surgery, Novelrad has specifically developed the NVCD closure device. It integrates a proprietary and revolutionary micro-suturing technology that mimics the standard surgical technique, effectively delivering a multipoint continuous suture in a minimally invasive manner. The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%, saving up to 15 min in the procedure, and bringing important cost savings related to same-day discharge and complications management. Importantly, with a single NVCD device large and extra-large bore closure of veins and arteries is possible (up to 30Fr).
After obtaining a fully functional prototype of the NVCD and advancing in pre-clinical tests, we now aim to perform a first-in-human (FIH) study and complete the clinical trial required to obtain its CE certification as a Class III medical device. This will be crucial to prepare for industrialization and commercial deployment in Europe and globally.

Ámbito científico (EuroSciVoc)

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Tema(s)

Régimen de financiación

HORIZON-EIC-ACC-BF - HORIZON EIC Accelerator Blended Finance

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Convocatoria de propuestas

(se abrirá en una nueva ventana) HORIZON-EIC-2023-ACCELERATOR-01

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Coordinador

NOVELRAD LTD
Aportación neta de la UEn
€ 2 499 999,00
Dirección
KIBBUTZ METZER
3882000 METZER
Israel
Pyme
Sí
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Enlaces
Coste total
€ 4 121 068,75