FDA Grants Enexor Ventilator EUA

Franklin, Tenn.-based Enexor Health Systems announces that the U.S. FDA has granted an emergency use authorization (EUA) for the immediate delivery and use of the X-VENT ventilator. Enexor will start delivering ventilators to hospitals within a few days.

Guided by the medical team of physicians and respiratory therapists, led by Bill Walsh, MD, of Vanderbilt University’s Monroe Carrol Jr Children’s Hospital, the X-VENT was designed to deliver the critical modes of ventilations required for COVID patients. “The X-VENT is a sophisticated, complex, state-of the-art ventilator capable of providing multiple modes of mechanical ventilation,” says Walsh. “The engineers did an amazing job keeping it simple, easy to use. and inexpensive. It is exactly what the physicians of the world need to support their patients through acute respiratory failure.”

The X-VENT is one of the few FDA EUA-approved ventilators that does not use a bag valve mask resuscitator, or Ambu-bag. Instead, the X-VENT utilizes a piston-driven air system controlled by a Schneider Electric industrial-grade, programmable logic computer. The system is designed for many years of use, and is self-calibrating, so it can easily be stored, company officials say.

“Enexor was created to help solve major world problems,” says Enexor Health Systems CEO Lee Jestings. “In responding to COVID and future pandemics, we stayed true to our mission by putting together an incredible team of medical professionals, engineers, and manufacturing specialists with the ultimate mission of designing and manufacturing a durable, reliable, easy to maintain, and affordable ventilator that can be deployed at any hospital in the world to help save lives.”