Mallinckrodt (NYSE: MNK) announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR Plus MRI device for delivery of INOMAX (nitric oxide) for inhalation during MRI procedures.
The INOmax DSIR Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide) for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide (NO) to the patient. The INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.
“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,” said Dr. Stephen Welty, Professor of Pediatrics and leading neonatologist. “Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care.”
The FDA clearance is based on the determination of Substantial Equivalence to the INOmax DSIR. The modifications to INOmax DSIR for the INOmax DSIR Plus MRI device included hardware modifications to the cart, an update of the software to include an MRI set-up wizard and modified labeling. The INOmax DSIR Plus MRI has the same intended therapeutic effect and patient population as the previously cleared INOmax DSIR predicate device.
The INOmax DSIR Plus MRI is considered MR Conditional with the primary targeted use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. In addition, the INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.