FDA approves LungFit PH for persistent pulmonary hypertension of the newborn.- Beyond Air
Beyond Air announced that the FDA has approved LungFit PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only).
LungFit PH is the first device from the LungFit therapeutic platform of nitric oxide generators that uses a patented Ionizer technology and is the first FDA-approved product for Beyond Air. It generates on-demand nitric oxide from ambient air for the treatment of term and near-term neonates with hypoxic respiratory failure.
NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4–6.8/1,000 live births) with a mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins