Abbott Gets FDA OK to Start ZoMaxx Trial
Abbott Laboratories said that it has received conditional approval from the FDA to begin a U.S. clinical trial for its ZoMaxx drug-coated stent, pitting its stent against Boston Scientific's Taxus Express2.
Abbott will start enrolling the first 250 patients in the trial soon. The trial is expected to expand to 1,670 patients with coronary artery disease across more than 80 centers. The approval to start the trial is consistent with Abbott's anticipated FDA approval of the device in the second half of 2007. The primary endpoint of the trial is to compare how many patients who have been given the ZoMaxx or the Taxus and need to have the target blood vessel reopened after nine months.
Unlike the Taxus stent, which is coated with the anticancer drug paclitaxel, Abbott's ZoMaxx stent is coated with ABT-578, an immunosuppressant drug specifically designed to coat a stent to counter vessel renarrowing. Abbott is already comparing the ZoMaxx with the Taxus in clinical trials outside the U.S.