New Publication Analyzes Interhospital Transport of Newborns Using VERO Biotech's GENOSYL® Delivery System for the Delivery of Inhaled Nitric Oxide
ATLANTA, April 16, 2021 /PRNewswire/ -- GENOSYL® Delivery System, a novel tankless, cassette-based delivery system for Inhaled Nitric Oxide, can greatly facilitate the delivery of iNO during interhospital transport of newborns, according to a new publication in the Spring 2021 issue of the journal RT Magazine. The issue was released April 8, 2021.
New Publication Analyzes Interhospital Transport of Newborns Using VERO Biotech's GENOSYL® Delivery System for the Deliv
The publication – by Natalie Mitchell, MBE (VERO Biotech LLC, Atlanta, GA) Robert E. Newmyer, MD (Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago); Mary Cominek, RRT (Northwestern University Feinberg Scholl of Medicine, Chicago, IL); Rupa Crite, BSHS, RRT (VERO Biotech LLC); Heloisa Georgiev, RRT-NPS (VERO Biotech LLC); and Charles V. Pollack, Jr. MA, MD (Vero Biotech LLC; University of Mississippi Medical Center, Jackson, MS) – emphasizes how the management of persistent pulmonary hypertension of the newborn (PPHN) requires specialized, intensive care. And while there about 750 neonatal intensive care units (NICUs) in the US, approximately 30-40% of newborns with severe hypoxemia due to pulmonary hypertension who show a suboptimal or nonsustained response to iNO must be transported with advanced life support (ALS) capability and ongoing administration of iNO from one hospital to an oxygenation machine (ECMO)-capable center. Abrupt discontinuation of iNO therapy before transport in patients who have not improved oxygenation and hemodynamics can be harmful because of acute deterioration with severe hypoxemia ("rebound" pulmonary hypertension). Therefore, the standard of care is to transport such patients while continuing iNO treatment.
Moreover, while there are alternative iNO delivery systems available for transport, the authors point out that only GENOSYL® Delivery System has been approved by the U.S. Food and Drug Administration (FDA) for the administration of inhaled Nitric Oxide during interhospital patient transport. The approval comprises the broadest transport label available in the mobile critical care setting.
"Providing optimal care for patients needing inhaled nitric oxide during interhospital transport has long been a challenge for physicians, nurses, respiratory therapists and ambulance transport drivers," said Robert Newmyer, MD, Medical Director – Transport, Ann and Robert H Laurie Children's Hospital in Chicago, Illinois. "Transport vehicles are essentially mobile intensive care units and the GENOSYL® Delivery System was tested and proven effective and safe in the various environments that recreated the critical care unit."
Furthermore, the publication authors reassert the value of "on-label" use of a drug or device, primarily with respect to patient safety. First, the indication means that the FDA has evaluated the safety and efficacy of the product for that specific use and found it appropriate for use in patients who have specific treatment needs. It does not mean uses outside the approved labeling are not safe, it simply provides assurance that the overall approved use has been reviewed specifically by the FDA. Secondly, it provides guidance and "guard rails" within which that safety and efficacy are assured. This is particularly beneficial for the inexperienced or only occasional user, to have one process or one dosing regimen approved and explained. Third, it offers consistent information on any monitoring that should be applied when the patient is using the device or drug. Finally, a FDA labeled indication offers a potential pathway to reimbursement for use, so that uninsured, underinsured, and insured patients can all have access to the drug or device, and providers such as hospitals or transport companies do not have to absorb the cost of the therapy.
FDA approval of the VERO Biotech transport nitric oxide delivery system offers a streamlined approach to iNO use in acute care and in various transport settings. For those facilities that have adopted the GENOSYL® Delivery System, advantages include no need for training on new devices, the reassurance and time-saving of using an approved configuration, and an improved focus on patient safety for these vulnerable neonates as they are transported to higher levels of care.
About Inhaled Nitric Oxide
Prior to the approval of the GENOSYL® Delivery System, the only way to provide iNO was via large, pressurized gas cylinders and associated delivery systems.
Important Safety Information
Please visit www.vero-biotech.com for the full Prescribing Information for GENOSYL.
About GENOSYL® DS
About VERO Biotech LLC
VERO Biotech is dedicated to improving the lives of patients by leading the development of innovative technologies for inhaled nitric oxide delivery in the acute care hospital setting and beyond, wherever inhaled nitric oxide treatment is needed.
Forward Looking Statements
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SOURCE VERO Biotech LLC