NEWS

 

 

FOR IMMEDIATE RELEASE

Vent Multiplexor Receives FDA Emergency Use Authorization for Crisis Care Co-Ventilation During COVID-19 Pandemic

Emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New Haven Hospital is the first ever device designed to enable individualized ventilation care for two patients sharing a single mechanical ventilator.

Immediate distribution of Vent Multiplexor to hospitals across the country and around the world planned.

April 16, 2020, New Haven, Connecticut

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 life-saving 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 information@ventmultiplexor.com

Please be advised, the Vent Multiplexor is not an FDA approved device, and its authorization will only last for the duration of the FDA’s declaration that circumstances exist to justify the granting of the emergency use authorization.

For Vent Multiplexor LLC Media Inquiries

Ben Sosenko, 916-529-3641; bsosenko@rsgrp.com

For Yale New Haven Health Media Inquiries

Mark D’Antonio 203-506-5648; mark.dantonio@ynhh.org

 

 

FOR IMMEDIATE RELEASE

Vent Multiplexor Successfully Deployed at Yale New Haven Hospital for Crisis Care Co-Ventilation During COVID-19 Pandemic.

Emergency device developed by Vent Multiplexor LLC in collaboration with Yale New Haven Hospital is the first ever device designed to provide temporary dual patient rescue mechanical ventilation with individualized patient care until an additional ventilator is available to resume single mechanical ventilation.

Emergency Use Authorization for Vent Multiplexor During COVID-19 Pandemic Under Review with FDA; Immediate Distribution Planned for Emergency Use at Hospitals Around the World Facing Ventilator Shortages.

April 13, 2020, New Haven, Connecticut

Vent Multiplexor, LLC (www.ventmultiplexor.com) announced today the successful emergency deployment of the Vent Multiplexor device at Yale-New Haven Hospital. The pioneer emergency deployment of the Vent Multiplexor, a patent-pending co-ventilation device developed in collaboration with YNHH to provide individualized emergency crisis care for two adult patients requiring ventilation when limited to a single mechanical ventilator, successfully co-ventilated 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 life saving co-ventilation technology that may help reduce the clinical need for critical care mechanical ventilators during an emergency.

Dr. Peter Kahn, MD, Medical Director for Vent Multiplexor LLC, hailed the successful results of the April 7, 2020 emergency deployment at Yale-New Haven Hospital, calling it “a critical breakthrough in emergency crisis care during the COVID-19 pandemic.” Dr. Kahn explained, “We stand committed to supporting the entire medical community as we urgently look for ways to quickly develop and deploy novel solutions that are desperately needed to overcome the challenges of delivering emergency crisis care during the pandemic, including the challenge of delivering individualized patient care using co-ventilation strategies during temporary ventilator shortages.” Dr. Kahn continued, “we must do everything possible to deliver life-saving crisis rescue care; having an affordable, state of the art approach to individualized patient care during emergency co-ventilation will give hospitals yet another critical weapon in the fight to save lives.”

The crisis care 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, came after days of around-the-clock pre-clinical testing. Among other things, the Vent Multiplexor and associated clinical protocols underwent rigorous testing on critical care ventilators at Yale-New Haven Hospital, as well as on the TSI Inc. Certifier FA Plus, which is the calibration device used at YNHH to validate ventilator accuracy prior to deployment for patient care. The Vent Multiplexor performed precisely as intended, making it the first ever device developed and deployed to independently control the delivery of tidal volumes—a crucial component in the clinical management of patients with Acute Respiratory Distress Syndrome, which is frequently the case with ventilated patients that are critically ill with COVID-19—when two patients are sharing a single mechanical ventilator.

As part of the collaboration, Vent Multiplexor LLC agreed to produce the Vent Multiplexor at cost for Yale New Haven Hospital and license the technology to YNHH for their own internal use and development. Todd Higgins, President of Vent Multiplexor LLC, commented, “we believe the Vent Multiplexor will offer a significant and immediate contribution to emerging crisis care during the COVID-19 epidemic and look forward to our continued collaboration with Yale-New Haven Hospital as well as with local governments, non-profit organizations, and ventilator manufacturers around the world, as we work closely with the FDA to quickly secure emergency use authorization.” Mr. Higgins added that the entire mission behind the Vent Multiplexor has been to execute a four-week crisis plan to rapidly develop affordable ventilation technology that can be scaled and deployed now to help relieve ventilator shortages until more ventilators become available. “We are pleased with the progress but remain intensely focused on getting the Vent Multiplexor immediately into the hands of hospitals around the country, as well as in other parts of the world where hospitals face even more terrifying resource constraints, as they fight to save lives during the COVID-19 epidemic with a limited number of ventilators on hand.” The Vent Multiplexor is manufactured using 3-D printing technology and requires almost no production lead time. Once authorized by the FDA, Vent Multiplexor LLC anticipates that tens of thousands of units can be made available for almost immediate distribution as needed for emergency crisis care use during the COVID-19 pandemic.

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 March 31, 2020, the US Public Health Service released an open letter from the Assistant Secretary for Health and the U.S. Surgeon General for “Optimizing Ventilator Use during the COVID-19 Pandemic.” The open letter includes the following statement from the FDA: “The FDA does not object to the creation and use of the T-connector that meets specifications described in the instructions provided to us for use in placing more than one patient on mechanical ventilation when the number of patients who need invasive mechanical ventilation exceeds the supply of available ventilators and the usual medical standards of care has been changed to crisis care in the interest of preserving life. The FDA’s no objection applies during the duration of the declared COVID–19 emergency.”

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 appears to meet a minimum threshold of acceptability for further review and has been submitted to the Office of Health Technology 1 (OHT 1: Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices).

Vent Multiplexor LLC is working closely with the FDA to expedite completion of the EUA review so that the Vent Multiplexor can be authorized for immediate distribution. 

For Media Inquiries:

Ben Sosenko, 916-529-3641; bsosenko@rsgrp.com

For more information, contact us at information@ventmultiplexor.com or call 646-442-3453. Please be sure to include your hospital affiliation and type of ventilator in use in your email.

 

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