New INOmax inhaled nitric oxide device now available to US NICUs
FDA recently cleared device for newborns with PH
A new device to deliver inhaled nitric oxide gas to newborns with pulmonary hypertension (PH), is now available for use in hospital neonatal intensive care units (NICUs) across the U.S.
The rollout follows recent approval from the U.S. Food and Drug Administration of the next-generation device, the INOmax Evolve DS,
“We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care,” Lisa French, executive vice president and chief commercial officer at developer Mallinckrodt Pharmaceuticals, said in a company press release. “We will continue to work closely with our customers to support availability of the INOmax EVOLVE DS delivery system.”
When a baby is born and starts breathing, blood flow resistance in the lungs decreases, the lungs inflate, and oxygen is moved into the bloodstream. In babies with persistent pulmonary hypertension of the newborn, the lung blood vessels do not open fully, so pulmonary blood pressure stays high and organs may not receive enough oxygen.
Inhaled nitric oxide for consistency, safety
PH is high blood pressure in the blood vessels that supply the lungs, or pulmonary arteries. It is caused by the narrowing of the vessels that restrict blood flow. The active compound in INOmax, nitric oxide, is a vasodilator, meaning it widens and relaxes blood vessels, helping to reduce pulmonary arterial pressure, improve blood flow, and facilitate breathing.
INOmax was approved in the U.S. and the European Union to improve oxygenation in newborns or babies born later than 34 weeks of pregnancy with hypoxic respiratory failure (abnormally low levels of oxygen), in combination with breathing support and other approaches.
The company says the device allows the delivery of constant levels of nitric oxide with improved safety and automation.
The system is fully integrated and includes delivery and monitoring components, two mini-cylinders, and a touchscreen to facilitate use. It features automatic activation when a minimum level of oxygen is detected, and backup functions to automatically switch to another cylinder when one is empty.
Feedback from a pilot program was positive, Mallinckrodt said, noting that a respiratory therapist at one of the hospitals using the device praised its small size and streamlined design.
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