Technology | December 31, 2008

FDA Clears MR Angiography Imaging Agent

December 31, 2008 - The FDA today approved Vasovist Injection (gadofosveset trisodium), manufactured by EPIX Pharmaceuticals, is reportedly the first contrast imaging agent for use in patients undergoing magnetic resonance angiography (MRA).

Although MRA can be performed without the use of a contrast imaging agent, Vasovist is designed to provide a clearer image of blood vessels, compared to MRA without contrast, in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs.

Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer than injecting X-ray dye an artery, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage.

The active substance in Vasovist is gadolinium. The safety and efficacy of Vasovist was established in two clinical studies of patients with known or suspected aortoiliac disease. In the studies, patients underwent MRA with and without Vasovist and their scans were compared to standard X-ray pictures using contrast. MRA with Vasovist detected more arterial disease than MRA performed without Vasovist and the pictures were of improved technical quality.

The primary safety risks for Vasovist are allergic reactions and an ephrogenic systemic fibrosis, a rare syndrome that involves the thickening of the skin, joints, eyes and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist.

For more information: www.epixpharma.com

Related Content

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...
Non-Contrast MRI Effective in Monitoring MS Patients
News | Neuro Imaging | March 18, 2019
Brain magnetic resonance imaging (MRI) without contrast agent is just as effective as the contrast-enhanced approach...
Ultrasound Societies Urge FDA to Remove "Black Box" on Ultrasound Contrast Agents
News | Ultrasound Imaging | March 07, 2019
National and international ultrasound societies are urging the U.S. Food and Drug Administration to remove the “black...
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
Sponsored Content | Videos | Contrast Media | January 22, 2019
ITN Contributing Editor Greg Freiherr speaks with Guerb
Videos | Artificial Intelligence | December 21, 2018
Enhao Gong, Ph.D., founder of Subtle Medical, an artificial intelligence (AI) company that develops products to help
Guerbet Showcases Diagnostic and Interventional Imaging Solutions at RSNA 2018
News | Interventional Radiology | December 12, 2018
Guerbet LLC USA highlighted new and next-level product offerings and partnerships in contrast media, injectors,...
Guerbet Launches Multi-Use OptiVantage Contrast Media Injector in Europe
Technology | Contrast Media Injectors | December 05, 2018
Contrast agent company Guerbet recently announced that the OptiVantage multi-use contrast media injector is now CE...
VigiLanz and Cincinnati Children's Commercialize Real-Time Acute Kidney Injury Tracking
News | Contrast Media | November 30, 2018
VigiLanz and Cincinnati Children’s Hospital Medical Center recently announced a collaboration that leverages Cincinnati...
Artificial Intelligence May Help Reduce Gadolinium Dose in MRI

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

News | Contrast Media | November 27, 2018
Researchers are using artificial intelligence (AI) to reduce the dose of a contrast agent that may be left behind in...