Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. This approval covers the second-generation Genosyl device. The third-generation device — which recently received FDA approval — has not yet been tested with rebreathing anesthesia. The company expects data for this setting available for the newer system in the first quarter of this year.
Vero Biotech said in a news release that Genosyl is now the first and only iNO delivery device approved for rebreathing and non-rebreathing anesthesia methods. This improves patient care, saves money for the hospital and reduces environmental pollution, the company said.
The company said it expects benefits from this indication in the form of lower gas flows. This brings less use of costly anesthetic agents and savings for the hospital and increased patient comfort.
Additionally, seamless iNO delivery from the ICU through surgery to post-operative care streamlines the process, the company said. This results in workflow improvements and cost reductions.
Vero Biotech said anesthesiologists can continue to use rebreathing anesthesia to prevent potentially dangerous and time-consuming workarounds.
“We believe this new indication for our second-generation device will now provide significant benefits to the anesthesiology and surgical care communities whose patients require inhaled nitric oxide in the operating room setting,” said Brent V. Furse, CEO and president, Vero Biotech. “We have addressed an unmet need in facilitating rebreathing anesthesia, a further demonstration of our continuous commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face,” he added.
