Mallinckrodt’s INOmax Evolve DS features automated backup delivery and improved portability for infants in the neonatal intensive care unit.
RT’s Three Key Takeaways:
- Integrated Delivery System: The Food and Drug Administration (FDA) cleared a next-generation delivery system that includes a primary delivery unit, monitoring system, electronic blender, and automated backup delivery.
- Neonatal Indications: The device is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure.
- Hospital Launch: The system is expected to be available for use in US hospitals during the first half of 2024, according to the company.
INOmax Evolve DS is FDA-cleared for the delivery of INOmax nitric oxide gas for inhalation, according to Mallinckrodt plc.
The system features an integrated design that includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, and mini-cylinders. The device aims to meet the needs of neonatal intensive care unit (NICU) patients and providers through automation, safety features, and portability for intrahospital transport, according to the company.
“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,” said Peter C Richardson, executive vp and chief scientific officer, in a news release. “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.”
INOmax 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. The treatment is used in conjunction with ventilatory support and other agents and is indicated for a maximum of 14 days of use, according to the package insert.
The device uses a specially designed injector module that enables tracking of gas delivery system waveforms and the delivery of a synchronized, proportional dose of nitric oxide. The system is validated for use with specific ventilators and respiratory care devices, according to Mallinckrodt.
The INOmax Evolve DS is not currently available for purchase or use but is expected to be available in US hospitals in the first half of 2024, according to the company.
Source:
- https://respiratory-therapy.com/products-treatment/monitoring-treatment/therapy-devices/fda-clears-inomax-evolve-ds/
- https://www.inomax.com/inomax-evolve-ds
