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.
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
Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.
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.
GENOSYL® (nitric oxide) gas, for inhalation, 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.
Important Safety Information
- GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
- Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
- Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
- In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- The most common adverse reaction is hypotension.
- Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
- GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.
Please visit www.vero-biotech.com for the full Prescribing Information for GENOSYL.
About GENOSYL® DS
GENOSYL® DS is VERO Biotech’s lead product. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. GENOSYL® DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients and the easy-to-use interface and portability features.
About VERO Biotech LLC
VERO Biotech LLC (formerly known as GeNO LLC) is a biotechnology company focused on the design, development, and commercialization of next-generation products to address the unmet medical needs of patients with a variety of pulmonary and cardiac diseases.
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
This press release and any statements of representatives of VERO Biotech LLC related thereto that are not historical in nature contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to VERO Biotech’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “seeks,” “intends,” “plans,” “potential” or similar expressions, including statements with respect to the potential effects of its products and plans to assess and undertake next steps for VERO Biotech LLC. These statements are based upon the current beliefs and expectations of VERO Biotech’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond VERO Biotech’s control).
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