Mallinckrodt announces US-FDA clearance of INOmax EVOLVE DS delivery system and approval of INOmax mini-cylinder

Mallinckrodt plc, a global specialty pharmaceutical company, announced that the INOmax EVOLVE DS delivery system has been cleared by the US 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. 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.

Dr. Peter C. Richardson, MRCP (UK), executive vice president & chief scientific officer, said, "This achievement reflects our commitment over the past two decades to serve the needs of NICU patients by providing a next-generation INOmax delivery system with comprehensive safety features. The FDA clearance of the INOmax EVOLVE DS is a major milestone for our company, the dedicated team members who made this possible, and most importantly, for our critically ill patients and the NICU staff responsible for their care."

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 delivery system epitomizes the balance of thorough research, user-centered design, innovative solutions, and transformative outcomes. We commend the team behind the device for their exemplary work and contribution to the field," said Adam Shames, Chair, PDTG UCD Award.

The INOmax EVOLVE DS is not currently available for purchase, distribution, or use, but is expected to be available in US 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.

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies.

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