Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, has received 510(k) clearance from the Centre for Devices and Radiological Health (CDRH) branch of the US Food and Drug Administration (FDA) 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.
The Inomax DS and Inomax DSIR drug-delivery systems are part of a comprehensive offering known as the Inomax therapy package. In addition to use of Ikaria’s proprietary, FDA-cleared drug-delivery systems, the Inomax therapy package includes Inomax (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items.
Inomax is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
Inomax should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of Inomax may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients.