– The INOmax EVOLVE DS is our
next-generation nitric oxide delivery system that combines
mini-cylinder technology, automation, integration, and interaction
into one device1 –
– The INOmax EVOLVE DS is now available for
contracting and distribution for use in U.S. hospitals –
DUBLIN, Oct. 10,
2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical
company, today announced the rollout of the U.S. Food and Drug
Administration (FDA) cleared INOmax® EVOLVE™ DS delivery
system for the delivery of INOmax® (nitric oxide) gas,
for inhalation. This nationwide rollout follows the successful
introduction of the INOmax EVOLVE DS Pilot program.
The INOmax EVOLVE DS is our next-generation inhaled nitric oxide
delivery system with a fully integrated design and includes a
primary delivery system, a monitoring system, an electronic
blender, automated backup delivery, mini-cylinders, and
more.1 The INOmax EVOLVE DS is intended to help
meet the needs of neonatal intensive care unit (NICU) patients and
healthcare professionals by offering improved automation, which
enhances safety features, and a streamlined design that elevates
the user experience.1
Please see Applications and Device Warnings below.
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.2
INOmax is contraindicated in the treatment of neonates
dependent on right-to-left shunting of blood.2
Please see additional Important Safety Information for INOmax
below.
"We are excited to enter the nationwide rollout phase of our
next-generation INOmax delivery system for NICU patients and the
hospital staff responsible for their care," said Lisa French, Executive Vice President &
Chief Commercial Officer. "This innovation milestone reflects
our long-standing commitment to providing delivery system
options with comprehensive safety features.1 We
will continue to work closely with our customers to support
availability of the INOmax EVOLVE DS delivery system."
A few of the many INOmax EVOLVE DS features
include1:
- 1.4-lb mini-cylinders
- Automated pre-use checkout
- Pre-high-calibrated NO/NO2 gas sensor modules and
automatic low calibration
- Automatic cylinder switching when empty
- Electronic blender with automatic activation when a minimum
amount of oxygen flow has been detected
- Electronic medical record connectivity that transfers over 100
data parameters3
- Touchscreen display with an easy-to-use interface
The comprehensive INOmax EVOLVE DS Pilot program provided users
the opportunity for an extensive review of our next-generation
delivery system. We appreciate each hospital's feedback including
one Respiratory Therapist's (RT) statement that, "After
using the INOmax EVOLVE DS during the pilot introduction, and in
current use, it is evident that Mallinckrodt took the input from bedside RTs into
account. The smaller cylinders and streamlined design make it
easier to move the device around the hospital and store
supplies."1
INOmax has a well-established efficacy and safety profile with
more than 20 years on the market and over 875,000 patients treated
globally.2,4 In 2023, the INOmax EVOLVE DS
was awarded the Human Factors and Ergonomics Society Stanley Caplan
User-Centered Product Design Award, presented to teams that have
demonstrated outstanding innovation and design for products,
software, and systems. Mallinckrodt
accepted the award on February 15,
2024.
If a customer is interested in learning more about the INOmax
EVOLVE DS, they can reach out to their local representative or
visit INOmax.com for the latest updates.
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 (>34
weeks gestation) neonates with hypoxic respiratory failure (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
- 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.
- 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
system or that is not designed for INOmax mixtures. Using equipment
that is not specified can cause the system to malfunction.
- If an alarm occurs, safeguard the patient first before
performing troubleshooting procedures.
- Use only INOmax, pharmaceutical grade NO.
Rx Only
For technical assistance or for information on the INOmax EVOLVE
DS delivery system, call (877) 566-9466.
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.
Please see Full Prescribing
Information.
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 segment's
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; and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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 the INOmax EVOLVE™ DS delivery
system in U.S. hospitals in the future. The statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in
the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy;
satisfaction of, and compliance with, regulatory and other
requirements, including the clinical guidelines and protocols, and
hospital policies and practices; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
changes in market demand; issues with product quality,
manufacturing or supply, or patient safety issues or adverse side
effects or adverse reactions associated with INOmax (nitric oxide)
gas and the INOmax EVOLVE™ DS delivery system; and other risks
identified and described in more detail in the "Risk Factors"
section and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form
10-K , Quarterly Reports on Form 10-Q, and other filings with the
SEC, all of which are available on its website. The forward-looking
statements made herein speak only as of the date hereof and
Mallinckrodt does not assume any
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events and
developments or otherwise, except as required by law.
CONTACT
Media Inquiries
Green Room Communications
908-577-4531
mediainquires@grcomms.com
Investor Relations
Derek
Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of
a Mallinckrodt company. Other brands are trademarks of
a Mallinckrodt company or their respective owners.
©2024 Mallinckrodt. US-2400582 10/24
References
1 INOmax EVOLVETM DS Operation Manual.
Mallinckrodt Pharmaceuticals.
2 INOmax. Package insert. INO Therapeutics LLC;
2023.
3 EVOLVE DS. Serial Data Protocol for versions
01.04.09 and later. Technical
Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023.
4 Data on File – Ref-01753. Mallinckrodt
Pharmaceuticals.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mallinckrodt-announces-an-expanded-rollout-of-the-inomax-evolve-ds-delivery-system-in-us-hospitals-302271897.html
SOURCE Mallinckrodt plc