Automated mini-invasive surgical approach to the treatment of mitral insufficiency

Descripción del proyecto

Tratamiento mínimamente invasivo de las válvulas cardíacas

El corazón tiene cuatro cavidades y bombea la sangre a través del mismo número de válvulas, que impiden el retroceso de la sangre. La insuficiencia de la válvula mitral, situada entre la aurícula y el ventrículo izquierdos, suele afectar a las personas mayores y conlleva una operación a corazón abierto. En el proyecto MITrep, financiado con fondos europeos, se ha desarrollado un dispositivo que puede ayudar en la cirugía laparoscópica de las válvulas mitrales permeables fijando un anillo de poliéster a la válvula afectada mediante un catéter. Este método es adecuado para pacientes de edad avanzada y no requiere una estancia en cuidados intensivos ni una hospitalización prolongada. Lo más importante es que el dispositivo tiene el potencial de ser utilizado para la reparación de las otras válvulas en el futuro.

Objetivo

Mitral valve insufficiency is a heart condition, where blood is abnormally leaking out of the mitral valve. This condition mainly afflicts the elderly patients:
- 80% of patients aged 80+ show moderate symptoms (chronic fatigue, shortness of breath, palpitations, racing heart rate)
- 10% of patients above 75 with severe symptoms are at risk of a sudden death (stroke) within 5 years.
- Prevalence will double by 2030.
Mitral insufficiency is treated with open heart surgery (300,000 operations/year in the EU and the USA) followed by intensive care. But this operation is unbearable for fragile patients. Half of the patients above 75 are tagged inoperable because of their age.
Less invasive repair surgeries have been tested (annuloplasty by transfemoral surgery) but lack efficiency and safety and require highly skilled surgeons (not available in each hospital).
In this context, the company CMI’nov has developed MITrep, the first patented mini-invasive surgical device that automatically goes to the mitral valve with no trial and error to affix a leak-preventing ring on the valve.
It uses the transapical approach. Once the ring is anchored, the mitral valve returns to normal activity. No heavy post-surgery effects are expected. No intensive care required.

MITrep can be used by any surgeons : no need to be a mitral valve specialist. It will allow to halve the operation time (from 5 hours to less than 2 hours), reduce hospitalization time to 3 days (vs 5-8 days with 2 days in ICU) and cost about three times less than open heart surgery (30k€ vs 80+k€). It means a dramatic cost reduction for healthcare systems and a real improvement of the care of the elderly patient.

This project holds the ambition to build a new gold standard in valvuloplasty worldwide, starting with mitral repair and replicable to aortic and tricuspid valve repair. It is also a value driver for CMI’nov.
The Phase 1 project will validate the feasibility of MITrep before scale-up and deployment.