The outbreak of COVID-19 underlined the importance of optimal mechanical ventilation at the Intensive Care Unit (ICU). It confirmed that improving mechanical ventilation saves lives. Conventional mechanical ventilation relies on providing inspiration followed by uncontrolled, passive expiration. This uncontrolled expiration causes sudden collapse of the lungs, that may occlude distal lung parts, reducing functional lung volume over time. Moreover, sudden collapse causes shear stress in the lung tissue, leading to an inflammatory response in the already vulnerable body. Both effects cause longer ICU stays or even death.
Ventinova has developed a breakthrough solution: FCV is the only ventilation method available to control the expiratory flow, resulting in a smooth and natural respiration pattern. Currently, 12 small (randomized controlled) clinical trials and over 3,500 cases were performed, showing Ventinova’s new ventilation principle is potentially the best method to keep the lung open and to prevent lung damage.
We are convinced that new FCV ventilator, with working name ‘Jane’, will benefit all patients that require ventilation, as the patient’s body is better oxygenated and no longer has ventilation-induced damage to repair, allowing it to focus on healing the primary trauma / the lungs itself in case of lung-illness.
Pre-clinical and clinical data indicate that FCV technology has a more efficient oxygenation and CO2 removal, with less application of mechanical power, and does not cause Ventilator Induced Lung Injury (VILI). Incremental innovations iof the gold standards PCV and VCV have already reduced the mortality rate at ICU by 20% over the last 15 years. However, the quick wins are already won. To further reduce ICU mortality related to ventilation, a new disruptive principle is needed. FCV promises to fulfill this need. This does not only saves lives, but also obviously would result in considerably lower healthcare costs and improved day-to-day patient care.
At the start of the project FCV was available for use in the operating room and in selected ICU patients with required continuous direct supervision of an intensivist / anaesthesiologist. This project aimed to bring disruptive ventilation technology FCV to the ICU globally. The project consists of technological development, creating an ICU ventilator, and clinical validation, including observational data collection and comparative studies. Also, CE marking and dissemination to reach KOLs and medical doctors were part of the plan.
The following objectives were defined for the project:
• ICU prototype device shows potential benefit in various ICU patients in observational data
• Field demonstrator units available for studies
• CE marked (MDR) for 3 days of ICU ventilation
• Clinical benefits shown in distinct ICU patient groups
• CE mark (MDR) for ICU ventilation without undivided attention
