As the COVID-19 pandemic continues to develop, the global price of ventilators are high and seriously inadequate. Apex Medical Corp., the medical device company, who develops and manufactures the continuous positive airway pressure machine (CPAP), has recently released the integrated solution of its CPAP product with the new catheter design to provide mild and moderate COVID-19 patients with another respiratory treatment program.
Based on the dual guidance of the U.S. Food and Drug Administration (FDA) as well as the British Medicines and Medical Products Regulatory Agency (MHRA), CPAP has been clinically used to support COVID-19 patients with respiratory insufficiency in European countries and the United States. Professor Mauo-Ying Bien, the Former Chair of the School of Respiratory Therapy in Taipei Medical University, explains that despite the clinical indication of CPAP is mainly for treating sleep apnea, CPAP can still provide continuous positive airway pressure to maintain alveolar expansion, reduce the work of breathing and preserve blood oxygen level to relieve Hypoxia. For mild, moderate or recovering COVID-19 patient, this solution can be taken into account.
According to the integrated catheter CPAP solution proposed by the University of California, Berkeley, Apex Medical uses the existing CPAP machines with FDA 510 (k) medical device approval, European CE certification and Taiwan domestic registration as key component of the new ventilator. Its catheter design is also integrated with non-vented mask with two sets of high-efficiency filters, which can prevent the invasion of bacteria or viruses into the machine and the ward to reduce risk of infection to the caregivers.
At present, similar treatments have been proposed by CPAP manufacturers in Europe and the United States, and approved by their local medical institutions to be promptly inputted to clinical treatment of COVID-19 patients. As a patient-centered company with products and services in more than 60 countries, Apex Medical is actively finding the solutions to help nations around the world to overcome the threat of COVID-19 pandemic. In order to serve regions and countries outside Europe and the United States that require related medical device certification, such as the Asia-Pacific region, it is vital for Taiwanese government to grant license on this new ventilator solution. Regarding related procedures, Apex Medical is currently in close discussion with the Taiwan Food and Drug Administration (TFDA) and expects to speed up progress to timely deliver our aids to more countries suffering from the pandemic.
With the existing CPAP machines as the key component, Apex medical’s ventilator solution integrates a non-vented mask with two sets of high-efficiency filters, which can prevent the invasion of bacteria or viruses into the machine and the ward to reduce risk of infection to the caregivers.