FDA Clears Expanded Compatibility for INOMAXÃ‚® Drug-Delivery Systems
HAMPTON, N.J., March 21, 2012 /PRNewswire/ -- Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that the Center for Devices and Radiological Health (CDRH) branch of the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for compatibility of its INOMAX drug-delivery systems with three additional respiratory care devices. The INOMAX DS and the INOMAX DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems and other respiratory care devices.
The INOMAX DS and INOMAX DSIR are proprietary drug-delivery systems that deliver INOMAX® (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation and treats HRF in this fragile newborn population.
The FDA's clearance of these additional respiratory care devices for use with the INOMAX DS and INOMAX DSIR makes Ikaria's INOMAX drug-delivery systems fully compatible with the most commonly used invasive mechanical ventilation methods and non-invasive respiratory strategies in neonatal intensive care units (NICUs), including continuous positive airway pressure (CPAP) and nasal cannulae. This represents Ikaria's ongoing commitment to meet the needs of its customers by providing clinicians with the flexibility to safely deliver INOMAX to critically ill patients using many ventilation strategies.
The INOMAX drug-delivery systems are now compatible with the Fisher & Paykel Healthcare Bubble CPAP System and the Hamilton-C2 and Hamilton-G5 ventilators. For a complete list of ventil