Mallinckrodt plc announced that the INOmax® EVOLVE? DS delivery system has been cleared by the U.S. Food and Drug Administration (FDA) for the delivery of INOmax® (nitric oxide) gas, for inhalation. The INOmax EVOLVE DS delivers INOmax into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.

It uses a specially designed injector module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with the ventilators and respiratory care devices for which INOmax EVOLVE DS has been validated. INOmax 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.

INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. As a result of the FDA clearance, the INOmax EVOLVE DS will now become a next-generation nitric oxide delivery system with a fully integrated design and will include a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 The INOmax EVOLVE DS can help meet the needs of NICU patients and providers by offering improved automation, which enhances safety features, portability for intrahospital transport, and a streamlined design that elevates the user experience. The INOmax EVOLVE DS was also recently awarded the Human Factors and Ergonomics Society (HFES) Stanley Caplan User-Centered Product Design (UCD) Award for 2023.

This award is presented each year to teams that have demonstrated outstanding innovation and design for products, software, and systems across several categories. The INOmax EVOLVE DS is not currently available for purchase, distribution, or use, but is expected to be available in U.S. hospitals in the first half of 2024. INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.

Important Safety Information: 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. The INOmax EVOLVE DS and DSIR Plus delivery systems deliver INOmax (nitric oxide) gas, for inhalation. These delivery systems must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and are indicated for use in term and near term (>34 weeks gestation) neonates with HRF associated with clinical or echocardiographic evidence of pulmonary hypertension.

These delivery systems are indicated for a maximum of 14 days of use. Device Warnings: Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the EVOLVE DS eINOblender or the DSIR Plus INOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert.

Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. Do not use equipment that is not specified as part of the systems or that is not designed for INOmax mixtures.

Using equipment that is not specified can cause the systems to malfunction. If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. Use only INOmax, pharmaceutical grade NO.