COCOA, Fla., April 19, 2012 /PRNewswire/ -- New data presented today studied the safety of the GeNO system for delivering inhaled nitric oxide (NO) to patients being evaluated for cardiac transplant. GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, announced that a study of GeNO's NITROSYL Delivery System during Right Heart Catheterization (RHC) in subjects being evaluated for Orthotopic Heart Transplantation (OHT) and Left Ventricular Assist Device (LVAD) implantation was presented at the International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting in Prague, Czech Republic.
The study was led by Dr. Andrew Boyle, Medical Director of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Aurora St. Luke's Medical Center in Milwaukee, and evaluated 10 heart failure patients who underwent RHC prior to cardiac transplant or LVAD implant.
GeNO's NITROSYL Delivery System was used to deliver NO at a concentration of 80 PPM for 15 minutes by nasal cannula with air or O2. Results showed that in eight patients who received NO in air, the levels of nitrogen dioxide (NO2) in the gas that was delivered varied from 0.04 PPM to 0.06 PPM. Two patients received NO in O2 with NO2 levels in the gas varying from 0.25 to 0.35 PPM. Device performance was evaluated by measuring the amount of NO2 delivered to the patients as monitored by cavity attenuated phase-shift spectroscopy (CAPS) which can accurately detect NO2 down to 0.006 PPM. Cardiac hemodynamics were measured prior to and following 15 minutes of NO exposure. Clinically meaningful hemodynamic changes were not seen after such a short exposure to NO including PAP, PCWP, CO, CI, and PVR.
"The GeNO device reproducibly provided NO with low levels of NO2 in air or O2. The NO2 levels were considerably below the FDA limit of 3 PPM and O
|SOURCE GeNO LLC|
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