Descripción del proyecto
Un tratamiento novedoso se centra en el origen de la fibrilación auricular
La fibrilación auricular es un tipo de arritmia cardíaca que tiene lugar cuando la taquicardia ocasionada por impulsos eléctricos caóticos en las aurículas provoca contracciones descoordinadas y rápidas. Se trata de un trastorno potencialmente mortal con complicaciones graves, como accidente cerebrovascular, y presenta una elevada prevalencia en el mundo. El tratamiento más eficaz del que se dispone actualmente es la ablación cardíaca, que destruye específicamente el tejido cardíaco que desencadena el ritmo anormal. Sin embargo, este tratamiento requiere personal altamente cualificado y entraña un considerable riesgo de complicaciones. AtriAN Medical ha desarrollado un tratamiento novedoso que actúa específicamente en el origen de la señal que provoca la fibrilación auricular y evita la arritmia. Este tratamiento obtendría una elevada tasa de éxito y presentaría un menor riesgo de complicaciones. El actual proyecto Neuron-AFib, financiado con fondos europeos, finalizará los ensayos y la validación de la tecnología para cumplir los requisitos reglamentarios y, posteriormente, realizará un ensayo clínico sobre la eficacia y la seguridad del tratamiento con gran cantidad de pacientes.
Objetivo
Atrial Fibrillation (AFib) is a debilitating and life-threatening condition with a high and increasing prevalence worldwide. However current treatments have low success rates and have significant risks and complications. Moreover, the most widely used treatment – cardiac ablation - still has limited adoption with the majority of patients hesitant to be treated knowing the potential for poor outcomes and complications. In addition, current treatments have even lower success rates and higher complications in women.
AtriAN Medical is bringing a revolutionary treatment to market that is the first to specifically target the origin of the signal that causes AFib, thus eliminating the arrhythmia and disease progression. In addition to increased success rates, the AtriAN technology will reduce the risk of complications and the procedure will be done in a fraction of the time needed for current treatments; approximately 2 hours compared to 6-8 hours. The treatment will work equally well in women and men.
AtriAN conservatively estimates that it will have turnovers of €85M per annum within one year of regulatory approvals. AtriAN has a senior management team in place with significant medical device industry experience in technology development, manufacturing and scale up from start-up to multinational size.
AtriAN needs to perform a clinical trial in order to gain CE-marking to allow sales in Europe. AtriAN is planning for CE approvals by 2022 and FDA approval by 2026.
The proposed Neuron AFib project will first finalise the device testing and validation needed in order to meet regulatory requirements and will then perform the clinical trial, with equal female and male enrolment, in order to demonstrate safety and efficacy of the treatment. AtriAN has already raised €3.8 million of funds needed to close out research activities but needs another €2.4 million to execute on the testing, validation and clinical trial needed to reach CE approval and commercial launch.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEInst-2018-2020-2
Régimen de financiación
SME - SME instrumentCoordinador
H91W60E GALWAY
Irlanda
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.