GE Healthcare said that new safety data on its Optison ultrasound contrast agent were presented at this week's American Society of Echocardiography (ASE) scientific sessions in Montreal.
The poster presentation showed that Optison did not significantly affect pulmonary artery systolic pressure (PASP) or pulmonary vascular resistance (PVR) compared to baseline in patients with normal or elevated PASP, according to GE. Led by Dr. Michael Main of Saint Luke's Mid America Heart and Vascular Institute, the phase IV, single-blind, cross-over, placebo-controlled study compared the effects of Optison and a control (5% dextrose) on PASP and PVR assessed during right heart cardiac catheterization in 30 subjects.
The data were gathered under GE's new drug application (NDA) postmarketing commitment study, which was jointly designed by GE and the U.S. Food and Drug Administration (FDA).
