GeNO LLC. out of Waltham, MA won FDA clearance for its GeNOsyl MV-1000 inhaled nitric oxide (NO) delivery device.
Nitric oxide, an important regulator of pulmonary vasomotor tone, can be used in critically ill patients, such as infants with persistent pulmonary hypertension or lung transplant recipients, to improve ventilation-perfusion mismatch and hence oxygenation. Inhalational delivery of nitric oxide is a complicated business since only miniscule doses (on the order of a few particles per million) are required for therapeutic effects, and larger doses present significant potential toxicities.
More about the system:
The GeNOsyl™ MV-1000 delivery system incorporates four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer. The GeNOsyl™ MV-1000 injects a constant flow of nitric oxide gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient. It provides continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves two functions: 1) as a mixing chamber, and 2) to chemically convert to NO any nitrogen dioxide which may be present, so as to deliver NO with extremely low levels of nitrogen dioxide, a toxic byproduct.