FDA News

New indication for coronary computed tomography angiogram agent approved

GE Healthcare announced the FDA approved a new indication for an iso-osmolar agent for coronary CTA to diagnose patients with suspected CAD.

Physicians can produce images of coronary arteries using the agent, iodixanol (Visipaque, GE Healthcare) on both adults and children aged 12 years or older. The noninvasive outpatient procedure is an alternative to the traditional invasive coronary angiography approach, which costs more and often results in longer hospital stays, according to a press release issued by the company.

“Having an approved contrast agent for [cardiac] CTA may facilitate the use of [cardiac] CTA as a gatekeeper to [invasive coronary angiography] in patients with mild to moderate [CAD], sparing patients from a more invasive procedure and long recovery times,” Matthew J. Budoff, MD, professor of medicine at UCLA David Geffen School of Medicine and program director and director of cardiac CT in the division of cardiology at Harbor-UCLA Medical Center, said in the release.

Matt Budoff
Matthew J. Budoff

The agent has been assessed in two prospective, multicenter clinical studies, which showed that it had a 99% negative predictive value in diagnosing patients with CAD, according to the release.

Disclosure: Budoff reports receiving a grant from GE Healthcare.

GE Healthcare announced the FDA approved a new indication for an iso-osmolar agent for coronary CTA to diagnose patients with suspected CAD.

Physicians can produce images of coronary arteries using the agent, iodixanol (Visipaque, GE Healthcare) on both adults and children aged 12 years or older. The noninvasive outpatient procedure is an alternative to the traditional invasive coronary angiography approach, which costs more and often results in longer hospital stays, according to a press release issued by the company.

“Having an approved contrast agent for [cardiac] CTA may facilitate the use of [cardiac] CTA as a gatekeeper to [invasive coronary angiography] in patients with mild to moderate [CAD], sparing patients from a more invasive procedure and long recovery times,” Matthew J. Budoff, MD, professor of medicine at UCLA David Geffen School of Medicine and program director and director of cardiac CT in the division of cardiology at Harbor-UCLA Medical Center, said in the release.

Matt Budoff
Matthew J. Budoff

The agent has been assessed in two prospective, multicenter clinical studies, which showed that it had a 99% negative predictive value in diagnosing patients with CAD, according to the release.

Disclosure: Budoff reports receiving a grant from GE Healthcare.