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.1
Dr.
The INOmax EVOLVE DS was also recently awarded the
'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
The INOmax EVOLVE DS is not currently available for purchase, distribution, or use, but is expected to be available in
INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.2,3
IMPORTANT SAFETY INFORMATION (Cont'd)
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.
APPLICATIONS
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.
Rx Only
For information on the INOmax EVOLVE DS delivery system or for technical assistance for any of the INOmax delivery systems, call (877) 566-9466.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segments areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to INOmax (nitric oxide) gas, the INOmax EVOLVE DS delivery system, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of INOmax EVOLVE DS delivery system in the
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