Vent Multiplexor Receives FDA Emergency Use Authorization fo

|Apr 16|magazine16 min read

NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ -- Vent Multiplexor, LLC (www.ventmultiplexor.com) and Yale New Haven Hospital announced today that the Food and Drug Administration has granted Emergency Use Authorization for the Vent Multiplexor, a life-saving emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New Haven Hospital. The Vent Multiplexor is a patent-pending device designed to provide individualized emergency crisis care for two adult patients requiring mechanical ventilation when limited to a single mechanical ventilator. The FDA Emergency Use Authorization comes just over a week after Yale New Haven Hospital successfully deployed the Vent Multiplexor to co-ventilate two critically ill COVID-19 patients with different disease states, different lung sizes, and different tidal volume requirements, all while accurately measuring lung compliance of both patients in real time, a dramatic advancement in co-ventilation technology.

On April 1, 2020, in accordance with the Emergency Use Authorization for the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 pandemic, Vent Multiplexor LLC requested the addition of the Vent Multiplexor on the list of emergency use products authorized by the FDA. The EUA review was conducted by a cross-disciplinary team at the FDA's Office of Health Technology. Vent Multiplexor, LLC President, Todd Higgins, thanked the FDA review team for their support and the around-the-clock effort to expedite the Emergency Use Authorization for the Vent Multiplexor. "When the history of the COVID-19 pandemic is finally written, there will be a long list of heroes to thank. Included among them will be the dedicated public servants at the FDA quietly doing our Nation's work in partnership with the private sector to ensure that lifesaving innovation quickly finds its way to the frontline." With FDA authorization in place, Vent Multiplexor LLC will focus its attention on quickly ramping up production while also beginning work with partners in countries around the world where looming medical equipment shortages threaten a wave of humanitarian crises. Mr. Higgins explained, "Ultimately, we are all part of a global community. The call to action is for all of us to do everything in our power to help wherever that help is needed. We intend to answer the call."

Thomas Balcezak, MD, Yale New Haven Health's Chief Clinical Officer and EVP welcomed the FDA authorization. "Yale New Haven Hospital is proud to have collaborated with Vent Multiplexor LLC and other groups on the development and successful trial of new technologies. We are committed to doing everything in our power to bring urgently needed new technologies and treatments to the community in the fight against COVID-19." Dr. Peter Kahn, MD, Medical Director for Vent Multiplexor LLC, applauded the collaboration with YNHH and its leadership at the forefront of emergency crisis care during the Covid-19 pandemic. "We are immensely grateful for the tireless efforts of the entire team at YNHH and their unwavering support for the rapid development of the Vent Multiplexor. This would not have been possible without them."

The successful deployment of the Vent Multiplexor, which was initially developed by two of the co-founders of Vent Multiplexor LLC, Brian Beitler and Tim Foldy-Porto, both of whom are students at Yale University, followed days of pre-clinical testing of the device, which is designed to control the individualized delivery of tidal volumes for two adult patients during emergency co-ventilation. Jonathon Siner, MD, Medical Director-Medical Intensive Care Unit for Yale New Haven Hospital and Associate Professor of Pulmonary, Critical Care and Sleep Medicine at Yale School of Medicine, who led the COVID-19 critical care deployment of the device for YNHH, welcomed the Vent Multiplexor as an "important new tool" in the fight to deliver life-saving rescue care. Dr. Siner explained, "while we continue to hope for lower than predicted volumes of COVID-19 patients, we continue our planning for worst case projections. The Vent Multiplexor will help us to maintain critical care capacity during the pandemic and make a real impact in the MICU." Dr. Elaine Fajardo, MD, Medical Director of Respiratory Medicine and Assistant Professor at Pulmonary, Critical Care and Sleep Medicine at Yale School of Medicine, who oversaw development of the clinical protocols for the Vent Multiplexor at YNHH and the implementation with patients, added that "enhanced strategies for co-ventilation are a crucial component in contingency planning for emergency critical care as possible ventilator shortages emerge in health care systems. New technologies like the Vent Multiplexor are a critical part of the path forward as we work to save as many lives as possible. And we are happy that we can participate in their development."

Additional Information on the Vent Multiplexor

The Vent Multiplexor is a patent-pending co-ventilation device developed in Connecticut by Vent Multiplexor LLC, in collaboration with YNHH, as an emergency rescue device intended to provide individualized temporary rescue mechanical ventilation until an additional ventilator is available to resume single mechanical ventilation or as soon as respiratory recovery is attained in either patient. The Vent Multiplexor has the potential to help reduce the clinical need for ventilators during the COVID-19 pandemic, as it permits the emergency sharing of ventilators between two patients who are not equally matched, by delivering individualized tidal volumes, while also providing critical validation data on the quality of patient matching using existing "T-connector" and similar ventilator splitting technologies, a potentially revolutionary paradigm shift in the delivery of pandemic emergency respiratory care.

On April 1, 2020, in accordance with the Emergency Use Authorization ("EUA") for the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 pandemic, issued by the United States Food and Drug Administration ("FDA") for the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories, Vent Multiplexor LLC requested the addition of the Vent Multiplexor on the list of authorized products included on Appendix B of the EUA. On April 2, 2020, The FDA confirmed that the EUA request for the Vent Multiplexor was submitted to the Office of Health Technology 1 (OHT 1: Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices) for review. The FDA formally issued the EUA for the Vent Multiplexor on April 15, 2020.

The Vent Multiplexor is manufactured using 3-D printing technology and requires little production lead time. Vent Multiplexor LLC anticipates that thousands of units will be made available for distribution as needed for emergency crisis care use during the COVID-19 pandemic. For more information on the Vent Multiplexor, please contact Vent Multiplexor LLC at [email protected].

For Vent Multiplexor LLC Media Inquiries:
Ben Sosenko, 916-529-3641; [email protected]

For Yale New Haven Health Media Inquiries:
Mark D'Antonio 203-506-5648; [email protected]

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SOURCE Vent Multiplexor LLC