CIMEC   24726
CENTRO DE INVESTIGACION DE METODOS COMPUTACIONALES
Unidad Ejecutora - UE
informe técnico
Título:
Informe regulatorio para pre-submission FDA 510K de IMVALV SP
Autor/es:
FABIO A GUARNIERI
Fecha inicio/fin:
2019-04-10/2019-12-20
Naturaleza de la

Producción Tecnológica:
Regulatorio
Campo de Aplicación:
Tecnol.sanit.y curativa-Instrum.medico y od
Descripción:
The imValv System is a permanent implantable aqueous shunt to reduce intraocular pressure (IOP) in the anterior chamber of the eye. The System includes a pressure sensor to provide IOP measurement and monitoring hydraulic resistance. This measurement is used to guide treatment of Glaucoma. The system includes:Aqueous Shunt/Valve: A permanent implanted shunt/valve that reduces the IOP draining the aqueous humor of the anterior chamber of the eye to the subconjunctival space.IOP Sensor: A capacitive battery-free pressure sensor embedded in the implantable device to provide IOP measurement on demand.External Reader Unit (ERU): acquire and process signals from the IOP Sensor, and presents the IOP pressure data for review by medical professionals, who can make decisions regarding the status of the patient and initiate changes in medical therapy.