RESPIRA project has been developed under the supervision of Institut Català de la Salut (ICS) of the Government of Catalonia, with the cooperation of Hospital Clínic de Barcelona and Centre de Medicina Comparativa i Bioimatge del Institut de Recerca Germans Trias i Pujol - Can Ruti de Badalona, and with physicians from Hospital de Sant Joan de Déu de Barcelona. Moreover, the project has been developed in collaboration with Technology in Biomaterials (TiB). Following the classification rules provided by the Medical Device Regulation MDR 2017/745, the medical device RESPIRA has been catalogued as class IIb.
The medical device has overcomed a wide range of validation tests such as software, mechanical tests and biocompatibility, as well as acoustic, electromagnetic suscpetibility, electrical safety and vibrations and shocks, Applus certified. Furthermore, preclinical studies with adult and pediatric porcine models have been fulfilled.
In April the 9th 2020, the clinical trial “Reliability, security and clinical progress assessment of RESPIRA device use on patients with no access to assisted mechanical ventilation in COVID-19’s pandemics” and compassionate use of RESPIRA ventilator was authorized by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Spanish Health Ministry to be implemented at “Unified ICU” in Catalonia, composed by 45 ICUs included in the list provided by the promoter (FCRB).
This made possible for RESPIRA to help recover patients affected by COVID-19 during the pandemic when traditional medical ventilators were in shortage.
This clinical trial provided strong evidence and proofs the excellent results achieved by RESPIRA in patients requiring mechanical ventilation. Nowadays, the invasive mechanical ventilator RESPIRA device.com Advanced is about to complete CE marking, FDA, as well as additional certifications mandatory for the use of the device in several geographical areas.