Linde Gas & Equipment has applied for FDA approval of its NOXBOX® I PLUS, a system that delivers and monitors NOXIVENT® (nitric oxide) gas for medical use.
NOXIVENT gas is used to improve oxygen levels and reduce the need for extracorporeal membrane oxygenation in newborns with hypoxic respiratory failure and pulmonary hypertension.
It is given alongside ventilatory support and other treatments.
Linde has upgraded the NOXBOX® | PLUS with a streamlined setup process, ergonomic refinements, precise controls, and further compatibility with various ventilators.
Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment, said the FDA submission builds on the success of the NOxBOX®I delivery system.
“With the addition of the NOXBOX® I PLUS, we are committed to providing healthcare professionals with an enhanced system that offers an economical and reliable way to deliver inhaled nitric oxide therapy.”
The NOxBOX®i delivery system has been in commercial use in 40+ countries since 2013 and in the US since October 2018.
In the US, the NOxBOX®i delivery system is currently used in hundreds of locations.
Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment, said, “We look forward to NOXBOX I PLUS’ 510(k) clearance, and we remain steadfast in our commitment to nitric oxide therapy and continuous improvement in our technology.”
The recommended NOXIVENT dose is 20 ppm, maintained for up to 14 days or until the neonate is stable enough to be weaned from therapy. Higher doses are not recommended.
Clinicians should monitor PaO2, inspired NO2, and methaemoglobin levels during administration.
