This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: LungFit PH
PMA Applicant: Beyond Air, Inc
Address: 900 Stewart Avenue, Suite 301, Garden City, NY 11530
Approval Date: June 28, 2022
Approval Letter: Approval order
What is it?
The LungFit PH makes nitric oxide (NO) gas from room air and delivers it into the breathing circuit of a mechanical ventilator that is providing breathing support to a newborn (neonate). The LungFit PH includes a gas monitoring system to measure concentrations of nitric oxide, nitrogen dioxide (NO2), and oxygen (O2) in the breathing circuit. It also includes a backup nitric oxide system that delivers a fixed concentration of NO.
Studies have shown that nitric oxide therapy in some newborns with respiratory failure helps to improve the levels of oxygen in their blood and can reduce the need for extracorporeal membrane oxygenation (ECMO).
How does it work?
The LungFit PH is connected with a mechanical ventilator. A health care provider sets a target amount of nitric oxide on the LungFit PH. The LungFit measures the gas flow and delivers a flow of nitric oxide into the ventilator’s breathing circuit based on both the target amount and ventilator flow.
When is it used?
The LungFit PH is intended to improve the amount of oxygen in the blood and lower the need for ECMO in term and near-term (born at more than 34 weeks gestation) neonates while in the hospital. It is used when these newborns are not getting enough oxygen into the blood (hypoxic respiratory failure) due to high blood pressure in the arteries to the lungs (pulmonary hypertension) while on a ventilator and other breathing support.
What will it accomplish?
Studies have shown that nitric oxide therapy in some newborns with respiratory failure helps to improve the levels of oxygen in their blood and can reduce the need for extracorporeal membrane oxygenation (ECMO). The LungFit PH makes nitric oxide at the patient bedside from room air and does not require nitric oxide gas cylinders. Three primary studies showed lower rates of ECMO use for infants who received nitric oxide compared to those who did not.
When should it not be used?
The LungFit PH should not be used in neonates who are dependent on blood moving from right-to-left between the heart’s chambers (shunting).
Additional information (including warnings, precautions, and adverse events):