Artificial Right-Heart without External Power from Bench-to-Bedside

Descripción del proyecto

Innovador dispositivo para la insuficiencia cardiaca derecha en adultos

El tratamiento de la insuficiencia ventricular derecha con asistencia mecánica sigue siendo un reto clínico importante, que afecta a los resultados y la calidad de vida de los pacientes. Las soluciones actuales son costosas, complejas y conllevan riesgos como las infecciones y un mal control del flujo sanguíneo. Además, los pacientes con dispositivos de asistencia ventricular izquierda a menudo desarrollan insuficiencia ventricular derecha crónica, pero no existen dispositivos específicos para adultos. El proyecto HeartWise, financiado por la Consejo Europeo de Innovación, pretende colmar esta laguna desarrollando un dispositivo totalmente implantable y autoalimentado adaptado a partir de tecnologías pediátricas en fase inicial. Diseñado para pacientes adultos de Europa, así como de Oriente Próximo y Norte de África, ofrecerá asistencia circulatoria autónoma con hemodinámica ajustable.

Objetivo

Addressing right ventricular (RV) failure through mechanical circulatory support remains an intricate challenge, impacting patients' overall Quality of Life. Existing solutions are hindered by exorbitant costs, intricate device setups, infection risks, limited blood flow control, and hemocompatibility. Additionally, all patients with left ventricular assist devices face the risk of chronic RV failure. Despite a substantial untapped market for adult RV failure, there remains a critical gap in clinically-approved mechanical assist devices. The HeartWise initiative aims to revolutionize RV support with a dedicated device tailored to disease and eliminating the need for external power sources or control units. HeartWise builds upon two societally viable early-stage ERC-PoC technologies initially developed for the niche yet humanitarian pediatric device market. We aim to extend their application to adult disease markets, beginning with the MENA and European regions. The project integrates these two PoC technologies: circulation support devices that operate without external power AND patient-specific customized cardiovascular surgical planning. HeartWise aims to advance a revolutionary, fully implantable MCS prototype, akin to an artificial mechanical heart, for practical clinical implementation. This disruptive innovation marks a significant departure in ventricle assist devices, as it operates autonomously within the body without reliance on external power. Offering powerless circulatory support and globally accessible interactive patient-specific hemodynamic customization through the internet, we aim to scale-up these technologies to penetrate adult cardiovascular disease markets. Notably, it addresses a substantial market, serving a significant number of adult right heart failure patients. Our strategy involves rigorous testing, refinement of business prospects, and close collaboration with EU stakeholders.