Treating Cardiac Edema
Vasodilators May Improve Outcomes In Persistent Pulmonary Hypertension In Newborns
Various pulmonary vasodilators may improve outcomes in persistent pulmonary hypertension (PPH) in newborns, according to study results submitted to the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024, held virtually from September 27 to 30, 2024.
Inhaled nitric oxide is considered the primary treatment for PPH in newborns, which is associated with a significant increase in neonatal mortality and morbidity. Investigators compared the efficacy of various vasodilators as adjunctive therapy or as second-line therapy for management of PPH in newborns.
The investigators conducted a systematic review and network meta-analysis pooling results of 12 randomized controlled trials (RCTs; N=2911 patients) to analyze multiple treatment options including endothelin-1 receptor antagonists, phosphodiesterase inhibitors, and inhaled nitric oxide.
In the treatment group, compared with placebo, sildenafil and milrinone showed statistically significant reductions in hospital length of stay (mean difference [MD], -6.6 days [95% CI, -12.68 to -0.60] and MD, -6.9 [95% CI, -12.36 to -1.36], respectively).
Reducing treatment failure was most effectively accomplished with surfactant and nitric oxide, with statistically significant MDs (MD, -0.734 [95% CI, -1.30 to -0.17] and MD, -0.6 [95% CI, -0.81 to -0.38], respectively).
The treatment group, compared with placebo, showed no statistically significant differences in lowering side effects, improving oxygenation index, or improving mortality.
References:
Elrosasy A, Maher A, Hammam NG, et al. Efficacy and safety of vasodilators for the management of persistent pulmonary hypertension of the newborn: a systematic review and network meta-analysis. The Heart Failure Society of America Annual Scientific Meeting; September 27-30, 2024; Atlanta, GA. Abstract 052.
Beyond Air Provides LungFit® PH System To U.S. Naval Hospital Guam For Neonatal Critical Care In Partnership With TrillaMed
GARDEN CITY, N.Y., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, is proud to announce the deployment of its groundbreaking LungFit® PH system to the U.S. Naval Hospital Guam. This partnership, made possible through collaboration with TrillaMed, marks a significant advancement in the neonatal critical care unit, offering enhanced care for newborns in need of respiratory support.
The LungFit® PH system is an innovative device designed to generate Nitric Oxide (NO) from room air and deliver NO for the treatment of persistent pulmonary hypertension in neonates (PPHN), a condition that affects the lungs and heart of newborns. The system provides a safe, efficient, and user-friendly solution to address critical respiratory conditions, ensuring that the hospital's youngest and most vulnerable patients receive the highest standard of care.
Key Features of the LungFit® PH System:
"We are honored to support the U.S. Naval Hospital Guam in their mission to provide top-tier neonatal care," said Steve Lisi, CEO of Beyond Air. "Through our partnership with TrillaMed, we are able to extend the reach of our LungFit® PH, delivering critical solutions to the healthcare community. This collaboration is a testament to our commitment to advancing neonatal care and improving patient outcomes."
The U.S. Naval Hospital Guam serves as a critical care provider for the military community in the region. More than 17,000 active-duty military personnel and family members currently are stationed on Guam, which is expected to increase by 2,500 in the next two years. The U.S. Naval Hospital Guam delivers an average of 315 babies per year, with that number expected to rise to 487 births by 2033. The introduction of the LungFit® PH system underscores the hospital's dedication to utilizing state-of-the-art technologies in neonatal care, ensuring military families have access to the latest in respiratory treatment options.
About Beyond Air®, Inc.Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. For more information, visit www.Beyondair.Net.
About LungFit®*Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.G. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.G. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.
* Beyond Air's LungFit PH is approved for commercial use only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. Beyond Air's other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.
About Nitric OxideNitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About TrillaMed.TrillaMed is a premier provider of medical supplies and technologies to government and healthcare systems globally. As a trusted partner, TrillaMed delivers best-in-class solutions to meet the critical needs of healthcare providers, ensuring military personnel and their families receive the highest level of care.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.Com(212) 915-2577
Mallinckrodt Announces An Expanded Rollout Of The INOmax® EVOLVE™ DS Delivery System In U.S. Hospitals
– 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.
Mallinckrodt logo
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 MALLINCKRODTMallinckrodt 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 STATEMENTSThis 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 InquiriesGreen Room Communications908-577-4531mediainquires@grcomms.Com
Investor RelationsDerek BelzVice President, Investor Relations314-654-3950derek.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.
Cision
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SOURCE Mallinckrodt plc
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