Technology | CT Angiography (CTA) | June 16, 2017

FDA Adds Coronary CT Angiography Indication for GE Healthcare’s Visipaque Contrast Media

Visipaque is the first FDA-approved contrast agent indicated for non-invasive CCTA procedure 

GE Healthcares imaging agent Visipaque, iodixanol, is now cleared for use with cardiac CT angiography, CCTA

June 16, 2017 — The U.S. Food and Drug Administration (FDA) has expanded the indication for GE Healthcare’s 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.
 
“Coronary heart disease is a major cause of death in the United States,” said Matt Budoff, M.D., FACC, director of cardiac CT and professor of medicine, Harbor-UCLA Medical Center, Torrance, Calif. “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.”

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 percent negative predictive value in the diagnosis of CAD (study 1: sensitivity (76-89 percent), specificity (84-89 percent); study 2: sensitivity (95 percent), specificity (87 percent))[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 U.S. and Canada.

For more information: www3.gehealthcare.com/en/products/categories/contrast_media/visipaque

Related Content

Siemens Healthineers Demonstrates Artificial Intelligence, Healthcare Digitalization at HIMSS19
News | Artificial Intelligence | February 13, 2019
February 13, 2019 — At the 2019 Healthcare Information and Management Systems Society (HIMSS) global conference and e
Canon Adds Radiation Therapy Package to Aquilion Prime, Lightning CT Systems
News | Computed Tomography (CT) | February 11, 2019
In the patient-centric world of radiation oncology, it is critical that computed tomography (CT) simulation is...
Korean National Training Center Installs Carestream OnSight 3D Extremity System
News | Computed Tomography (CT) | February 07, 2019
Jincheon National Training Center in Jincheon, South Korea, installed a Carestream OnSight 3D Extremity System at its...
Canon Medical Debuts Alphenix 4-D CT at RSNA 2018
Technology | Angiography | February 06, 2019
Canon Medical Systems USA Inc. recently introduced a new angiography configuration featuring its Alphenix Sky + C-arm...
Sponsored Content | Case Study | Contrast Media | January 30, 2019
The medical imaging market relies heavily on contrast media, injected into patients to increase the contrast of bodil
MaxQ AI's Accipio Software Integrated to GE's Smart Subscription Platform
News | Computed Tomography (CT) | January 29, 2019
MaxQ AI and GE Healthcare announced that MaxQ's Accipio artificial intelligence (AI) platform will now be a part of GE...
Siemens Healthineers Debuts AI-Rad Companion Chest CT
News | Artificial Intelligence | January 25, 2019
Siemens Healthineers presented its first intelligent software assistant for radiology, the AI-Rad Companion Chest CT,...
Sponsored Content | Videos | Contrast Media | January 22, 2019
ITN Contributing Editor Greg Freiherr speaks with Guerb
3-D Reconstruction of Ichthyosaurus Skull

A 3-D reconstruction of the ichthyosaurus skull from a computed tomography (CT) scan. Image courtesy of Nigel Larkin, taken at Royal Veterinary College, London.

News | Computed Tomography (CT) | January 09, 2019
A nearly meter-long skull of a giant fossil marine ichthyosaur found in a farmer's field more than 60 years ago has...