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A small percentage of newborn babies born in the U.S., typically 2%, experience hypoxic respiratory failure (HRF), which may be caused by persistent pulmonary hypertension, a condition in which the blood vessels in the lungs narrow, restricting oxygen supply. In such cases, appropriate patients may be treated with an inhaled therapy.5 These patients are typically treated in a hospital’s Neonatal Intensive Care Unit (NICU).

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The patient in this situation is often placed on a respiratory device such as a ventilator. A breathing tube may be inserted through the nose or mouth, or ventilatory support may be performed. The drug, in the form of therapeutic gas, is injected into this ventilator flow.1,&nbsp;5 Administering this therapy requires a sophisticated delivery system to control the concentration of the drug that is delivered in doses of parts per million.&nbsp;

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When INOmax (nitric oxide) for gas, inhalation therapy is initiated, continuous delivery of the drug throughout the duration of treatment is important.&nbsp;INOmax is contraindicated in the treatment of neonates dependence on right-to-left shunting of blood.&nbsp;An abrupt disruption of therapy can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome).3 Please see additional important safety information below.
The <a href="https://www.inomax.com/inomax-evolve-ds/" target="_blank">INOmax® EVOLVE™ DS</a>&nbsp;delivery system is a device used&nbsp;for this therapy.4 It is used by respiratory therapists in a hospital’s Neonatal Intensive Care Unit.&nbsp;Please see applications and device warnings for the EVOLVE DS <a href="#applications">here.</a> Given the environment in which these delivery devices are used,&nbsp;the EVOLVE DS delivery system is equipped with features designed to help mitigate delivery interruptions.&nbsp;The eINOblender within the EVOLVE DS serves as a backup delivery device and can be used to reinstate INOmax therapy.4
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Select Device Warnings 
<ul><li>Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert </li></ul>
Please see additional Device Warnings below.
<ul></ul>

Development of the EVOLVE DS was formulated using&nbsp;extensive user research with over 400 clinicians2 and designed to mitigate risk through technical redundancy and appropriate feedback to the technician. To understand opportunities for human factors improvement with existing INOmax delivery devices, contextual inquiry and discovery research were conducted that spanned hospitals, conferences, a clinical advisory board, and searches of internal and external feedback.2 After cataloging and prioritizing the pain points and defining user needs, conceptualization and user testing with low-fidelity user experience models was conducted. Each model represented a different combination of features and functionality, each addressing the user needs in a different way.2
Over the course of the design and development of the EVOLVE DS, a total of 25 user studies were performed, each with a higher fidelity user experience model or update to a user interface. Input from hundreds of nurses and respiratory therapists from dozens of hospitals guided the emerging design.2

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The final design of the EVOLVE DS aims to reduce user- and device-related risks in iNO therapy for newborns by improving device usability and ergonomics: 
<ul><li>Uses 1.43-lb, 0.4-L mini-cylinders. Each cylinder weighs 1.43 lb, contains 4,880™ ppm of inhaled nitric oxide&nbsp;and is filled to 3000 psi.3</li></ul>
<ul><li>Automated cylinder management. Automated cylinder switchover to alternate bay when cylinder is depleted. Dedicated cylinder displays show percent full when no dose is set, or run-time remaining when a dose is set.4</li></ul>
<ul><li>Automated pre-use checkout. Fully automated after initial connections are made and correct flow is set within range. An on-screen dashboard shows progress while the automated pre-use checkout is running and, once complete, it displays the results of each subsystem check.4 </li></ul>
<ul><li>No high calibrations required. Factory-calibrated eINOcal™ Module eliminates the need for high calibrations. Low calibrations are automated.4 </li></ul>
<ul><li>Electronic eINOblender™ backup with automatic activation. The eINOblender automatically activates when the required minimum oxygen flow to the manual resuscitator is detected. Its dose is auto-set to match the primary delivery system dose.4 </li></ul>
<ul><li>Portable, fully integrated system. The INOmax EVOLVE DS device head can be removed from the cart. The primary delivery system, monitoring system, two cylinder bays, eINOblender, and additional backup systems are all integrated into a single enclosure.4</li></ul>
<ul><li>Touch-screen display with on-screen wizards. Wizards assist with automated pre-use checkout, alarm help, and on-screen ventilator setup.4 </li></ul>
<ul><li>EMR connectivity enabled. Dose, monitored values, cylinder information (pressure level, run-time remaining, percent full), alarm information, and many other parameters are automatically streamed to the patient’s medical record.4, 6 </li></ul>
<ul><li>Electronic Injector Module. Bidirectional flow detection (60 L/min reverse flow to 160 L/min forward flow). Low flow accuracy (full accuracy down to 0.5 L/min). Low ventilator flow resistance (the flow in the ventilator circuit passing through the injector module is not restricted).4 </li></ul>

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APPLICATIONS 
The INOmax EVOLVE DS delivery system delivers INOmax (nitric oxide) gas, for inhalation. The EVOLVE DS must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and is indicated for use in term and near term (&gt;34 weeks gestation) neonates with HRF associated with clinical or echocardiographic evidence of pulmonary hypertension. The EVOLVE DS is indicated for a maximum of 14 days of use. 
DEVICE WARNINGS 
<ul><li>Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert. </li></ul>
<ul><li>Do not discontinue INOmax delivery if the high NO2 &nbsp;alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. </li></ul>
<ul><li>Do not use equipment that is not specified as part of the system or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the system to malfunction. </li></ul>
<ul><li>If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. </li></ul>
<ul><li>Use only INOmax, pharmaceutical grade NO.</li></ul>
Rx ONLY
For technical assistance or for information on the INOmax EVOLVE DS delivery system, call (877) 566-9466. &nbsp; IMPORTANT SAFETY INFORMATION (continued) 
<ul><li>Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.</li><li>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.</li><li>In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.</li><li>Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.</li><li>INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.</li></ul>
PRESCRIBING INFORMATION 
View <a href="https://www.inomax.com/downloads/Inomax-PI.pdf" target="_blank">prescribing information.</a>

REFERENCES 
1 - Hilgendorff A, Apitz&nbsp;C, Bonnet D, Hansmann&nbsp;G.&nbsp;Pulmonary hypertension associated with acute or chronic lung diseases in the preterm and term neonate and infant. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK.&nbsp;Heart. 2016; 102 Suppl 2:ii49-ii56. doi:10.1136/heartjnl-2015-308591.&nbsp;
2 - Data on File – Ref-06558. Mallinckrodt Pharmaceuticals.
3 - INOmax. Package Insert. Mallinckrodt Pharmaceuticals.
4 - INOmax EVOLVE™ DS Operation Manual. Mallinckrodt Pharmaceuticals.
5 - Pandya S, Baser O, Wan GJ, et al.&nbsp;The burden of hypoxic respiratory failure in preterm and term/near-term infants in the United States 2011-2015 J HEOR. 2019;6(3).&nbsp;
6 - EVOLVE DS. Serial Data Protocol for versions 01.04.09 and later. Technical Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt Pharmaceuticals company. Other brands are trademarks of a Mallinckrodt Pharmaceuticals company or their respective owners. ©2024 Mallinckrodt. US-2400807 10/24

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A device that is used in the neonatal critical care environment that is designed to reduce device-related workflow. Improved automation adds enhanced safety features to the INOmax® (nitric oxide) gas, for inhalation, delivery system portfolio.

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A device that is used in the neonatal critical care environment that is designed to reduce device-related workflow. Improved automation adds enhanced safety features to the INOmax® (nitric oxide) gas, for inhalation, delivery system portfolio.

A device that is used in the neonatal critical care environment that is designed to reduce device-related workflow. Improved automation adds enhanced…

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Mallinckrodt: INOmax® EVOLVE™ DS Delivery System

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