Project description
New superior mechanical ventilators, utilising FCV, for intensive care patients
The outbreak of COVID-19 highlights the importance of mechanical ventilation in intensive care units (ICUs). However, current ventilation methods are not optimal and may damage the lungs of patients. The damage usually occurs during the passive, fast and uncontrolled expiratory phase of mechanical respiration, resulting in shear stress and collapse of the distal lung parts. Besides, prolonged ventilation may lead to inflammatory conditions in the lungs. Ventinova Medical (Netherlands) has developed a new ventilation method called FCV, with expiration control, preventing lung damage. Clinical studies and over 2 000 patient cases have already shown the lung protective potential of FCV: it keeps the lung open, provides a better gas exchange and does not result in significant lung damage. The objective of the EU-funded Jane project is to bring this new ventilation technology to ICUs in Europe, the Middle East and the USA.
Objective
The current outbreak of COVID-19 is incisively pointing towards the importance of optimal mechanical ventilation in Intensive Care. Improved mechanical ventilation saves lives. Last year, we have seen multiple cases in which our mechanical ventilator suited only for the Operating Room (OR), was used off-label in ICU to ventilate severely lung-ill patients. Doctors claim patients would have died if our device would not have been used. These case reports are supported by more fundamental evidence published in March 2020: in-vivo studies on pigs having similar lung-illness as with the current COVID-19 outbreak (called Acute Respiratory Distress Syndrome) have shown superior result with our disruptive ventilation method, called FCV®.
Half of all patients on higher grade Intensive Care Units need mechanical ventilation. However, current ventilation methods are known to damage the lungs in these vulnerable patients. This significantly prolongs ICU stay and increases mortality.
The damages relate to the passive expiratory phase during mechanical respiration, which is fast and uncontrolled resulting in shear stress and collapse of the distal lung parts. Prolonged ventilation then initiates inflammatory responses in the lungs. We have developed a new ventilation method controlling the expiration, preventing lung damage.
In 2017 our innovative OR ventilator (Evone) was brought to the market. Having performed over 1,000 OR patient cases and 5 small clinical studies till date, clear superior ventilation and improved lung mechanics has been shown. However, the largest unmet medical need related to ventilation is on ICU. The objective of this proposal is to bring this superior ventilation technology to ICUs in Europe, the Middle East and in 2nd phase the USA and by that, lower ICU mortality by 20% and ICU stay with 15%.
This means 44,800 lives to be saved in European ICUs, each year (valued at € 90 billion) and a reduction of €2 billion in annual European healthcare costs.
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Funding Scheme
SME-2 - SME instrument phase 2Coordinator
5652 BJ Eindhoven
Netherlands
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.