Innovative Technology Minimizes Need for Invasive Mechanical Ventilation
Posted on 01 Mar 2022
An early extracorporeal respiratory support system that elevates oxygen saturation levels is designed to be a new standard of care as a second-line treatment to minimize the need for invasive mechanical ventilation (MV).
Inspira Technologies’ (Ra'anana, Israel) ART system has been awarded the 2021 Europe Technology Innovation Leadership Award by Frost & Sullivan based on findings from its analysis of the European artificial respiratory market. Inspira is developing the ART system, a cost effective early extracorporeal respiratory support system with an intent to function as an "Artificial Lung" for deteriorating respiratory patients. The ART is designed to utilize a hemo-protective flow approach aimed at rebalancing oxygen saturation levels while patients are awake and breathing, potentially minimizing the patient's need for mechanical ventilation.
A variety of ART system features set it apart from ECMO. ECMO treatment requires two large cannulas (21-25 French) single lumen cannulas used to withdraw and return 5 to 7 liters of blood per minute. In comparison, the ART treatment is designed to use one dual-lumen cannula (16 to 21 French) for withdrawing and returning 1 to 1.5 liters of blood per minute. Moreover, ECMO is a high-flow device that cannot support low-flow treatment; the ART system optimizes the effectiveness profile of the low-flow extracorporeal treatment. The ART includes a proprietary disposable support cartridge with an oxygenator, tubes, and pump-head. The cartridge is a fully sterilized, closed system that incorporates an innovative auto-priming system that prevents air embolisms and minimizes the need for perfusionists who are necessary for ECMO operation.
Patients are medically induced into a coma during ECMO treatment, whereas the ART system aims to treat patients while they are awake and spontaneously breathing. There is no need for induced medical comas with the ART system, allowing patients to breathe spontaneously and communicate with their surroundings, thus reducing the risks and complications associated with MV. The company expects submission of the Class II 510(k) for its' Extracorporeal Life Support system (ECLS) in H1-2023, followed by initial market penetration in the respiratory care industry. Furthermore, the company plans to file its novel treatment, the ART system, for de-novo or PMA to the US Food and Drug Administration (FDA) in H2-2023.
"Inspira Technologies' ART system differs significantly from extracorporeal membrane oxygenation (ECMO) in many areas, including its intent of use, patient population, system size, and potential risks for the patient," noted Debarati Sengupta, Industrial Analyst at Frost & Sullivan. "Unlike standard ECMO treatment, the ART system allows for early intervention. Alternative treatments, such as invasive mechanical ventilation, can be applied alongside the ART system if a patient's health continues to deteriorate. The ART system demonstrates the company's excellence in innovation within the respiratory care industry."
"Inspira will potentially overcome the complicated setup associated with ECMO and other systems, resulting in an efficient and effective procedure that safeguards a patient's health," added Samantha Fisher, Best Practices Research Analyst for Frost & Sullivan. "The innovation of the ART system is that it overcomes the limitations of its predecessors to deliver a less-invasive respiratory support system."
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