Mallinckrodt has begun a national rollout of the INOmax Evolve DS delivery system, which is FDA-cleared to provide inhaled nitric oxide to certain neonatal ICU patients in order to improve oxygenation and reduce the need for extracorporeal membrane oxygenation.

RT’s Three Key Takeaways

  1. The INOmax Evolve DS is Mallinckrodt’s next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device
  2. The INOmax Evolve DS is now available for contracting and distribution for use in US hospitals
  3. The FDA cleared the INOmax Evolve DS for delivery of inhaled nitric oxide in December 2023


Mallinckrodt plc has expanded its rollout of the FDA-cleared INOmax Evolve DS delivery system. The INOmax Evolve DS is the company’s next-generation inhaled nitric oxide delivery system with a fully integrated design that includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 

The system is intended to help meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience,1 the company says.

INOmax inhaled nitric oxide 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.2

“We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care,” said Lisa French, Executive Vice President & Chief Commercial Officer. “This innovation milestone reflects our long-standing commitment to providing delivery system options with comprehensive safety features.1 We will continue to work closely with our customers to support availability of the INOmax Evolve DS delivery system.”

System features include:1

  • 1.4-lb mini-cylinders
  • Automated pre-use checkout
  • Pre-high-calibrated NO/NO2 gas sensor modules and automatic low calibration
  • Automatic cylinder switching when empty
  • Electronic blender with automatic activation when a minimum amount of oxygen flow has been detected
  • Electronic medical record connectivity that transfers over 100 data parameters3
  • Touchscreen display with an easy-to-use interface

Pilot Program

The comprehensive INOmax Evolve DS Pilot program provided users the opportunity for an extensive review of the delivery system. One piece of feedback from a respiratory therapist stated: “After using the INOmax Evolve DS during the pilot introduction, and in current use, it is evident that Mallinckrodt took the input from bedside RTs into account. The smaller cylinders and streamlined design make it easier to move the device around the hospital and store supplies,”1 the company reported in a press release.

More information, including important safety information, is available at at the company’s website.