BESANÇON – 04.12.2023 – Archeon Medical has received U.S. Food and Drug Administration (FDA) clearance for its EOlife®, the first smart device that measures the quality of manual ventilation. This approval marks a significant milestone for Archeon on its mission to promulgate the practice of high-performance ventilation.
A LONG-AWAITED AI-POWERED DEVICE
EOlife® is the first device that measures ventilatory parameters and gives a real time feedback on the quality of the manual ventilation provided to the patient in cardio-pulmonary arrest. Oxygen is a lifesaving essential medicine that is still administered without measurement. By using advanced AI algorithms, EOlife® guides first responders in delivering an oxygen volume tailored to the patient’s lung profile. This is the first device that allows practicians to comply with resuscitation guidelines from the American Heart Association.
“We think the next step to ensure clinicians are delivering the highest quality ventilation is to have a portable device that can be used in the prehospital environment and accurately measure ventilation characteristics, especially ventilation rate and tidal volume.” said Pr. Mohamud Daya, and Dr. Matthew Neth, respectively EMS Section Chair and Assistant Professor at the Oregon Health & Sciences University.
AN ANSWER TO SIGNIFICANT PUBLIC HEALTH ISSUES
While the survival rate in cardio-pulmonary arrest is only 5%, a well-conducted ventilation doubles the chances of survival (ii). EOlife® improves the quality of manual ventilation by +70% while dividing the risks of hyperventilation by 10 (iii). By preventing those risks, a good ventilation improves the chances of survival, reduces the long-term pulmonary sequelae and the length of intensive care stays (iv). The use of EOlife® in the United States could save approximately 25,000 lives each year and could represent a significant cost saving valued at $20,000 per patient (v).
“It is time for health authorities and learned societies, like the American Heart Association, to regulate the practice of manual ventilation, now that users have the possibility to accurately control oxygen delivery to patients. It is simply unacceptable that a procedure as vital as manual ventilation is not better taught and regulated. Too many lives have been stupidly lost… This has to change…”, said Alban De Luca, co-founder of Archeon.
“The device developed by Archeon Medical offers an opportunity to enhance the quality and safety of ventilation in all patients undergoing manual ventilation. We believe that with proper training, this device can be quickly and easily applied to a manual ventilation system in the prehospital and in-hospital
setting.” Dr. Joseph Finney and Dr. Fahd Ahmad, respectively Director of Emergency Medical Services and Director of research, Washington University in St. Louis School of Medicine.
AN UNIQUE COMPETITIVE ADVANTAGE
The FDA clearance news comes in the wake of the recent and successful North American launch of EOlife X®, the ultimate training device for a high-performance ventilation.
“Designed in collaboration with users, our EOlife® technology is now available to first responders and clinicians, both in the field and during training. We are proud to bring our life-saving high-performance ventilation solution to American first responders”, said Pierre-Edouard Saillard co-founder of Archeon. “Our mission is to make cutting-edge technologies available to as many healthcare professionals as possible, in order to improve patient care. Archeon is driven by innovation. This is why we are striving to make high-performance ventilation a widespread practice. The US manual ventilation market represents 40% of the world market and our company will make all the efforts to meet this market by strengthening our teams and our distribution network.”
i WHO/UNICEF «technical specifications and guidance for oxygen therapy devices», 2019
iiChang MP, Lu Y, Leroux B, Aramendi Ecenarro E, Owens P, Wang HE, Idris AH. Association of ventilation with outcomes from out of hospital cardiac arrest. Resuscitation. 2019 Aug;141:174-181
iii Khoury A, De Luca A, Sall FS, Pazart L, Capellier G. Ventilation feedback device for manual ventilation in simulated respiratory arrest a crossover manikin study Scand J Trauma Resusc Emerg Med. 2019 Oct 22;27(1):93
iv Mongardon N, Perbet S, et al. Infectious complications in out-of-hospital cardiac arrest patients in the therapeutic hypothermia era. Crit Care Med. 2011;39(6):1359-1364.
v Joseph F Dasta 1, Trent P McLaughlin, Samir H Mody, Catherine Tak Piech. Daily cost of an intensive care unit day: the contribution of mechanical ventilation a. Crit Care Med. 2005 Jun;33(6):1266-71.