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The FDA has approved the production and use of PREVENT, PVA’s ventilator designed and manufactured in its Cohoes, New York headquarters to address ventilator shortages in the United States and globally due to the coronavirus pandemic.
PREVENT is approved under the FDA’s Emergency Use Authorization (EUA), a fast track process passed in response to the spread of COVID-19. This authorization permits a wider supply base to produce ventilators and medical supplies during emergencies such as the coronavirus pandemic. PVA is the first company in New York State to receive design and manufacturing authorization. PVA is also the first non-medical device company in the world to receive FDA approval to design and manufacture ventilators under the COVID-19 EUA.
PREVENT is unique to existing emergency ventilators on the market due to its ability to titrate lung volume based on real patient data. A manually adjustable PEEP valve and an intuitive LCD screen allows clinicians to easily set and monitor tidal volume, peak inspiratory pressure breaths per minute and inspiratory to expiratory ration in real time. An active alarm system provides immediate feedback to clinicians.
Unlike traditional ventilators that require extensive training to use, PREVENT is designed to be extremely user-friendly for healthcare professionals on the frontline of COVID-19. Medical personnel that may be asked to help in an ICU or with COVID-19 patients due to the realistic possibility of limited staff will be able to use PREVENT quickly, easily and confidently.
PVA is slated to begin shipping ventilators by April 30 and has set capacity at 250 units per day. It is priced at a fraction of the cost of a traditional ventilator, making it ideal for communities and countries that are concerned about the coronavirus pandemic but have economic restrictions.
“Governor Cuomo and President Trump have repeatedly called on Corporate America to fill the void in manufacturing medical devices. Well, here we are. In one short month, we have taken a concept through to FDA approval,” stated PVA President Tony Hynes. “To be the only company in New York State to receive authorization and the only alternative company in the world to be recognized by the FDA for ventilator production is something our team can be proud of at PVA. Someone, somewhere may now have a chance to survive COVID-19 because of what we are doing here in Albany.”