Nitric Oxide Inhalation Device for MRI Procedures Cleared by FDA

The US Food and Drug Administration (FDA) have cleared a system for use with neonates that require MRI procedures and a constant concentration of nitric oxide (NO) inhalation therapy gas in the patient-breathing circuit.

The system, provided by a leading specialty biopharmaceutical company, enables continuity of care and uninterrupted nitric oxide for inhalation therapy for neonates, and increases delivery options.

The FDA cleared the Mallinckrodt (St. Louis, MO, USA) INOmax DSIR Plus Magnetic Resonance Imaging (MRI) device for delivery of INOMAX (nitric oxide) during MRI procedures only with validated and compatible Magnetic Resonance Conditional ventilators, identified in the device labeling.

The FDA clearance is based on the determination of Substantial Equivalence of the new INOmax DSIR Plus MRI device to the INOmax DSIR. The delivery systems consist of the INOblender delivery system unit, a stand/cart, and INOmax cylinders. The new device features modified cart hardware, delivery cable and tubing, gas sampling tubing, MRI set-up wizard software, and modified labeling, but has the same intended therapeutic effect and is intended for the same patient population as the INOmax DSIR. The new device is considered MR Conditional for use with only with 1.5 T and 3.0 T static magnetic field scanners, where the field strength is less than 100 gauss.

Dr. Stephen Welty, professor of pediatrics and leading neonatologist, said, "Neonates being treated with INOmax frequently have multiple medical concerns that may need diagnostic imaging, such as an MRI scan, to guide medical management. Before INOmax DSIR Plus MRI, physicians had to make the difficult decision to take the risk of interrupting INOmax treatment so that imaging could be done. Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care.”

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