Thursday, December 16, 2010
Stress Echocardiography New and Improved?
No. BILLERICA, Mass. (December 13, 2010) – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension for use in stress echocardiography. DEFINITY® is currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border1. With this acceptance, the FDA will now review the sNDA to determine whether or not to broaden the FDA-approved indication for DEFINITY® to include its use with exercise and pharmacologic stress testing.
Several labs have been using intravenous ultrasound contrast for years when performing stress echos because the border definition is better for most studies when contrast is applied. One of the downsides to a stress echo is the loss of wall definition at peak exercise even in patients who have fairly good windows. Contrast adds an extra level of insurance that the walls will be seen better in most echos. It is news to me that the FDA has not approved contrast for use in stress echo, but has approved it for many years in resting echocardiography. Perhaps the up side here is that labs can now be re-reimbursed for using contrast in this capacity. I had erroneously thought that the FDA had already approved intravenous ultrasound contrast for both resting and stress echos. Live and learn.