INOmax must be delivered through a special drug delivery device. The Food and Drug Administration (FDA) has specified that these drug delivery devices must meet particular specifications.
INOmax delivery devices should allow for operator-determined concentrations of nitric oxide in the breathing gas, and the concentration should be constant throughout the respiratory cycle. The delivery device should also monitor for PaO2, methemoglobin, and nitrogen dioxide (NO2). INOmax must be delivered through a system which does not cause generation of excessive inhaled NO2.
In the ventilated neonate, precise monitoring of inspired nitric oxide and NO2 should be instituted, using a properly calibrated analysis device with alarms. The system should be calibrated using a precisely defined calibration mixture of nitric oxide and nitrogen dioxide, such as INOcal. Sample gas for analysis should be drawn before the Y-piece, proximal to the patient. Oxygen levels should also be measured. In the event of a system failure or a wall-outlet power failure, a backup battery power supply and reserve nitric oxide delivery system should be available.
The primary INOmax delivery device is the INOvent. The INOvent meets all of the FDA-required specifications for INOmax drug delivery devices. The INOvent is available in two formats; a standard bedside unit and a Transport INOvent. The only difference between the standard and Transport units is that the Transport INOvent has a longer battery life of three hours.
While the INOvent is the standard INOmax Drug Delivery Device, Ikaria® is preparing to launch a new Drug Delivery Device in order to even better meet the needs of transport patients and personnel. The new Drug Delivery Device, called INOmax DS (for INOmax Delivery System), is significantly smaller and lighter than the current INOvent for Transport. Even though the INOmax DS is smaller and lighter, the drug delivery technology is the same as in the INOvent, so there is no compromise in quality.
While the INOvent will remain the bedside standard for INOmax Delivery Devices for years to come, the INOmax DS will also fill that role as the need for INOmax delivery devices increases.
