The INOmax EVOLVETM DS, created by Mallinckrodt and in partnership with Delve, is an investigative system for the delivery of INOmax® (nitric oxide) gas for inhalation. The EVOLVE DS is currently with the FDA and not cleared; The EVOLVE DS and the features described here are subject to a pending 510(k) application. At this time, the EVOLVE DS is not available for sale, distribution or use.

INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.[i] Please see Important Safety Information for INOmax below.

The EVOLVE DS includes many user interfaces: the delivery system itself, nitric oxide cylinders, an Operation Manual, various disposable accessories, and training materials. If cleared by FDA, the EVOLVE DS would typically be used in series with a ventilator in a Neonatal Intensive Care Unit (NICU).  Primary users are respiratory therapists with nurses interacting with the device in certain circumstances. 

IMPORTANT SAFETY INFORMATION FOR INOMAX

• INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.

• Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.

• Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

• In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.

• Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.

• INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System. 

Please see Full Prescribing Information.

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