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2020/08/06
Multi-center clinical study shows the ELICIAE MV20 to be a safe and effective solution for treating critical COVID-19 patients

Metran are pleased to announce the successful completion of a multi-phase, multi-center clinical study using the ELICIAEMV20, in Vietnam. The study was sponsored by Metran Co., Ltd of Japan, with support and financial participation from Van Lang University and Van Thinh Phat Group of Vietnam. Phase I of the trial was conducted at the Bach Mai Hospital, Hanoi, with 10 subjects treated. Phase II was conducted with 51 subjects at the Bach Mai Hospital, and the Cho Ray Hospital, Ho Chi Minh, in intensive care and emergency departments. During the trial, subjects already being treated on the hospitals’ standard ventilators were moved onto the ELICIAE MV20, and their vital signs were monitored for any changes. The overall findings of the Phase I/II study were that patients’ vital signs were maintained at a satisfactory level after moving them onto the ELICIAE MV20. Analysis of blood gas indicated that the level of oxygen and carbon-dioxide in the subjects stayed within a normal range. One case of CO2 increase was observed, and no related to the ELICIAE MV20’s performance. No others safety concerns were observed in this study. The ELICIAE MV20 was used without technical errors due to either the machines or operators. The investigators’ feedback was recorded using a post-use System Usability Questionnaire. ELICIAE MV20 was graded as above average score for system usefulness, information quality, and interface quality.

Background of Metran’s COVID-19 emergency ventilator project At the time of writing, already 17 million people around the world have been infected with a new form of SAR- Co2, named COVID-19 disease by the WHO. One of the characteristics of COVID-19 patients is lung injury and respiratory dysfunction. Acute Repsiratory Distress Syndrome (ARDS) was reported as an important symptom in COVID-19 patients. With the number of COVID-19 patients increasing every day, there is a high demand for safe and effective ventilators. Responding to the pandemic announced by the WHO, Metran, a Japanese medical device manufacturer with a long history of innovative and effective ventilatory solutions, has developed a specialized ventilator named the ELICIAE MV20, tailored to the specific needs of this pandemic. The solution provides a ventilator based on pressure control, that is safe and effective, that is simple to operate with just 1-2 hours of training, and that provides a solution to eliminate cross-infection. Importantly, this ventilator is suitable for mass-production and is low-cost.

About ELICIAE MV20 ELICIAE MV20 is a compact, safe, and easy-to-use artificial ventilator. The ELICIAE MV20’s main breathing modes are full mandatory ventilation, back-up mode and monitoring mode. In mandatory ventilation mode, the ELICIAE MV20 provides complete respiratory control in patients with severe pulmonary dysfunction. In back- up mode, the flow sensor detects patient’s breathing efforts and initiates mandatory breaths when an apnea is detected, using both flow and time triggers. In monitoring mode the patients tidal volume is monitored and CPAP support is provided, as well as continued supply of gas with the required oxygen mix. The Venturi valve system in the ELICIAE MV20 ventilator allows it to operate in sync with the spontaneous breathing cycle in all breathing modes, without air flow resistance occurring. The ELICIAE MV20 ventilation system uses heat and moisture exchangers with bacterial filters (HME). The ELICIAE MV20’s closed exhaust system enables capture of the patient’s exhaled air, which can be removed with a gas scavenger system prior to discharge into an environment outside of the patient room. This is important in minimizing cross infection to other patients and medical personnel. The ELICIAE MV20 requires minimal time for training and set up, which is critical in the case of the pandemic due to the shortage of highly trained medical personnel. The ELICIAE MV20 was designed by Metran using the best of Japanese engineering discipline in usability, testability, quality, and manufacturability. It is a lightweight ventilator system designed for rapid rollout inchallenging environments. It has been optimized for high-quality mass production based on Metran’s ISO13485-certified Quality Management System (QMS). This QMS ensure the high-quality standard manufacturing standard at all production sites in Japan and Vietnam.

About Van Lang – Van Thinh Phat Van Lang University and Van Thinh Phat Group has become premium sponsors to the Metran – COVID19 respond project. Van Lang University is a high-quality human resource training center which meets demand of the labor market and actively contributes to change of lifestyle, the way people think and work through education, research and community service. By 2025, Van Lang University will become a high-position university in the system of applied orientation universities of Vietnam; equal to the universities in the area on learning environment, scientific research and technology transfer. To build Van Lang University to become a multi-branch and multi-level university, ensure the training quality; as a reliable address for learners; as a reliable partner of universities, research institutes, domestic and foreign enterprises regarding training cooperation, scientific research and technology transfer.

Product inquiries: International Division:support_en@metran.co.jp

 

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