Chalfont St. Giles, UK, – Broadening its range of diagnostic options for clinicians and their patients, GE Healthcare announced today that it has received an indication approval from the U.S. Food and Drug Administration (FDA) for its imaging agent Visipaque™ (iodixanol) Injection. Visipaque 320 mg Iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of adult and pediatric patients 12 years of age or older with suspected coronary artery disease in the United States.
The new CCTA indication allows healthcare practitioners to image the coronary arteries of patients with suspected coronary artery disease (CAD), offering a non-invasive approach to diagnosis. Traditionally, radiologists and cardiologists have utilized Invasive Coronary Angiography (ICA) procedures to diagnose potential CAD in patients, which can be costly and result in longer patient hospital stays. With Visipaque’s CCTA label extension, healthcare practitioners now have an FDA-approved contrast agent in CCTA procedures that can be performed as an outpatient procedure when evaluating patients with suspected CAD.
According to Matt Budoff, Professor of Medicine at UCLA, “Coronary heart disease is a major cause of death in the United States. We are excited about the label extension of Visipaque™ as the first FDA approved iodinated contrast media for use in CCTA. 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,” said Emmanuel Ligner, General Manager of GE Healthcare’s Core Imaging business. “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. “
Label extension approval for VISIPAQUE 320 mg Iodine/mL for CCTA was evaluated in two prospective, multicenter clinical studies in a total of 1,106 adult patients. Data from the two studies showed that Visipaque™ has a 99% negative predictive value in the diagnosis of CAD (study 1: sensitivity (76-89%), specificity (84-89%); study 2: sensitivity (95%), specificity (87%))[1]. Visipaque’s label extension further enhances GE Healthcare’s cardiology portfolio , joining, Myoview, Adreview, and the recently announced distribution rights for Rapiscan outside the US and Canada.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
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