GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography.
The new indication allows doctors to image coronary arteries of patients to help diagnose coronary artery disease using a non-invasive technique. Traditionally, healthcare practitioners use invasive coronary angiography procedures to diagnose coronary artery disease.
“Coronary heart disease is a major cause of death in the United States. We are excited about the label extension of Visipaque as the 1st FDA approved iodinated contrast media for use in CCTA,” Matt Budoff, professor of medicine at UCLA, said in prepared remarks. “Having an approved contrast agent for CCTA may facilitate the use of CCTA as a gatekeeper to ICA in patients with mild to moderate coronary artery disease, sparing patients from a more invasive procedure and long recovery times.”
“Technology to image the coronary artery has improved dramatically over the past decade and we are delighted to complement these developments with an extension to the approved use of Visipaque,” Emmanuel Ligner, GM of GE Healthcare’s Core Imaging biz, added. “GE Healthcare is focused on continued innovation and investment in our contrast media portfolio to deliver a range of options for our customers and their patients, and we believe the CCTA label extension is an excellent development for patient care.”
The new indication approval was based on 2 clinical trials enrolling a total of 1,106 patients, according to GE. Data from the studies showed that Visipaque had a 99% negative predictive value in the diagnosis of coronary artery disease.