FDA clears INOmax EVOLVE DS, next-generation nitric oxide system

Device expected to be in use for infants in NICUs in US in 2024

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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An infant peacefully naps with arms outstretched.

INOmax EVOLV DS, a device to deliver nitric oxide gas by inhalation to newborns with pulmonary hypertension (PH), is expected to be available in hospitals in the U.S. in the first half of 2024.

The U.S. Food and Drug Administration (FDA) has cleared the next-generation device, developed by Mallinckrodt Pharmaceuticals.

It soon will be used for some of the youngest patients with PH: The INOmax EVOLV DS is expected to be employed in the neonatal intensive care unit, known as the NICU.

“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,” Peter C. Richardson, executive vice president and chief scientific officer at Mallinckrodt, said in a company press release.

“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,” Richardson said.

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The active component of INOmax, nitric oxide, is a powerful vasodilator, meaning it widens and relaxes blood vessels in the lungs. That in turn helps to reduce pulmonary arterial pressure, improve blood circulation, and ease breathing.

INOmax was approved in the U.S. and the European Union to treat hypoxic respiratory failure, a potentially life-threatening complication associated with PH. It’s indicated for newborns and babies born near-term — after more than 34 weeks of pregnancy.

Specifically, INOmax EVOLV DS was designed to have enhanced automation and safety, delivery of a constant concentration of nitric oxide, and lower device-related workflow. It can be used with ventilators and respiratory care technologies for which the device has been validated.

Its fully integrated design includes a primary delivery and a monitoring system, with mini-cylinders and an automated backup delivery, among other features.

The design of INOmax EVOLV DS was awarded this year’s Human Factors and Ergonomics Society Stanley Caplan User-Centered Product (UCD) Design Award, which recognizes outstanding innovation and product design.

“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 of the Product Design Technical Group UCD Award.


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