Mallinckrodt Pharmaceuticals Receives FDA Clearance For INOmax DS(IR) Plus MRI Device

CHESTERFIELD, United Kingdom, Nov. 16, 2015 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR® Plus MRI device for delivery of INOMAX® (nitric oxide) for inhalation during MRI procedures.

The INOmax DSIR Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide) for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide (NO) to the patient. The INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.

“Neonates being treated with INOmax frequently have multiple medical concerns that may need diagnostic imaging, such as an MRI scan, to guide medical management. Before INOmax DSIR Plus MRI, physicians had to make the difficult decision to take the risk of interrupting INOmax treatment so that imaging could be done,” said Dr. Stephen Welty, Professor of Pediatrics and leading neonatologist. “Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care.”

The FDA clearance is based on the determination of Substantial Equivalence to the INOmax DSIR. The modifications to INOmax DSIRfor the INOmax DSIR Plus MRI device included hardware modifications to the cart, an update of the software to include an MRI set-up wizard and modified labeling. The INOmax DSIR Plus MRI has the same intended therapeutic effect and patient population as the previously cleared INOmax DSIR predicate device.

The INOmax DSIR Plus MRI is considered MR Conditional with the primary targeted use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. In addition, the INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.

Technological Characteristics
All versions of INOmax DSIR family of delivery systems utilize component technology to deliver INOmax to the patient. The components consist of the Delivery System unit, the INOblender®, a stand/cart and INOmax cylinders. In this version of the INOmax DSIR, the cart hardware, the INOmax delivery cable and tubing, the gas sampling tubing, the software, and the labeling have been updated specifically for use in the MRI suite.

“INOmax DSIR Plus MRI was developed with the goal of enhancing patient care and making it easier for physicians to perform an MRI while maintaining their patients on INOMAX therapy,” said Steven Romano, MD, Senior Vice President and Chief Scientific Officer, Mallinckrodt Pharmaceuticals.

The company is committed to making the new device available in November 2015.

ABOUT MALLINCKRODT
Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology; neonatal critical care respiratory therapies; and analgesics and central nervous system drugs. The company’s core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company’s Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

About INOMAX®
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 in conjunction with ventilatory support and other appropriate agents. INOMAX should not be used in the treatment of neonates dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin NO2, and FiO2 should be monitored during nitric oxide administration.

About INOmax DSIR® for MRI 
The INOmax DSIR uses a “dual-channel” design to provide delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shut down INOMAX delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender can also be used for backup.

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