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From Spain: GPAINNOVA’s RESPIRA Emergency Ventilation Device Receives Approval from the Agencia Española de Medicamentos y Productos Sanitarios to Carry Out a Clinical Trial

GPAINNOVA, located in Barcelona Spain is leading the way in what they define as the RESPIRA project, focusing all their equipment and resources on the design of their medical ventilator in record time. The company reports that Siemens Digital Industries is its main partner and also has the support of SMC, TEG, and MAM.

GPAINNOVA reports the RESPIRA device prototype automates manual resuscitators type AMBU, assisting them automatically and monitored.

The clinical trial will now be carried out with patients affected by COVID-19, which is the last step before homologation by Agencia Española del Medicamento y Productos Sanitarios (AEMPS) of the Ministry of Health. The validation tests have been carried out following the guidelines of the AEMP and under the supervision of the Institut Català de la Salut (ICS) of the Catalonian Government, and are being performed at the Hospital Clínic of Barcelona and at Centre de Medicina Comparativa I Bioimatge del Institut de Recerca Germans Trias i Pujol – Can Ruti in Badalona, and also has the participation of medical experts from the Hospital de Sant Joan de Déu in Barcelona.

The Catalan multinational company GPAINNOVA is leading the RESPIRA project to respond to the global health emergency with the creation of a new prototype of a medical ventilator that is in high demand and which is essential to save lives of those most seriously affected by COVID-19 virus.

In the last two weeks, GPA has yielded all its equipment and resources to the RESPIRA project to create a prototype that allows the manual resuscitation devices (BVM or AMBU) to be activated automatically, giving a more adequate response to patients in front of the lack of approved automatic ventilators.

RESPIRA device, unlike other prototypes that are being developed, has extra features that allow monitoring of patient’s variables in a personalized way and can be controlled remotely providing easier management in hospitals. The devices are portable and have a robust design.

The device includes the necessary electronics to remotely control and monitor variables such as the frequency and volume of air and oxygen supplied to the patient with technology provided by SIEMENS and through a high-performance drive device manufactured by SMC. The use of a control station allows managing up to 16 devices simultaneously through its own Wi-Fi network.

On Tuesday, March 31st, validation tests ended at Hospital Clínic of Barcelona with a simulator and on April 1st they were tested in animals, at Centre de Medicina Comparativa I Bioimatge (CMCiB) del Institut de Recerca Germans Trias I Pujol – Can Ruti in Badalona. At the same time, as established by the guidelines of the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) of the Ministry of Health, electromagnetic compatibility tests have been carried out to ensure that the device does not interfere with other devices and medical equipment. Finally, yesterday the authorization of AEMPS has been received for the clinical trial with patients affected by Covi-19, which is the last step before the homologation.

RESPIRA project has been developed together with Hospital Clínic and Hospital Germans Trias I Pujol – Can Ruti and under the supervision of Dr. Josep M. Nicolás, a specialist in intensive care medicine at Hospital Clínic and professor at Universitat de Barcelona (UB); Dr. Ramón Farré, professor of Physiology at UB and head of the IDIBAPS Biophysics, Respiratory and Bioengineering group; and Dr. Manel Puig, from Instituto de Investigación Hospital Germans Trias i Pujol – Can Ruti. The project also counts on the participation of Joan Grasas, an entrepreneur in health technology and an innovation consultant linked to Institut Català de la Salut (ICS) of Catalonian Government and doctors Jaume Pérez Payarols, Martí Pons, Maria Cols and Arnau Valls from Hospital de Sant Joan de Déu of Barcelona for the definition of the requirements, the development of the device and validations. GPAINNOVA team is in contact with AEMPS to ensure the accomplishment of all standards and product homologation as a matter of urgency.

The entire production team is ready to start manufacturing once the device is approved by AEMPS. GPAINNOVA calculates that initially, they will be able to produce between 150 and 200 units per day, up to 1,000 units per week and progressively will increase production up to 300 units per day. To make this possible, production tests have already been carried out on the assembly line to manufacture the devices used in the clinical study with patients affected by COVID-19. RESPIRA device was created by GPAINNOVA with the support of partners as SIEMENS for electronics, SMC for electrical actuators, electrical assembly and wiring is done by TEG and manufacturing of cases and final assembly, and calibration is done by MAM. From the first moment, the project has had the support of Secretaría General de Industria y Pyme del Ministerio de Industria, Comercio y Turismo, which has constantly monitored its development, accompanying and advising GPAINNOVA, as well as Agencia Española del Medicamento y Productos Sanitarios del Ministerio de Sanidad, which has processed the authorization in record time.

Once RESPIRA device is released, GPAINNOVA will offer training and assistance services to facilitate its use by healthcare professionals in hospitals that require it.

RESPIRA device automates manual resuscitation devices (BVM or AMBU), currently widely available in medical centers, and can automatically and continuously assist the patient. Thus, RESPIRA device expands the number of respirators that can function without the need for continuous and manual actuation by medical staff. This complements the respirators commonly used by medical teams. It is a machine that saves lives by controlling and monitoring the parameters necessary to assist human respiration.

Additional details, contact information can be found here.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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