Abbott has received conditional approval from the US FDA for its Investigational Device Exemption (IDE) application for the ZoMaxx drug-eluting stent. As a result, the company will soon begin enrolling the first 250 patients into its ZOMAXX II drug-eluting coronary stent clinical trial in the United States. The start of enrolment into the trial is consistent with anticipated US approval for ZoMaxx in the second half of 2007.
The ZOMAXX II trial will enrol 1,670 coronary artery disease patients in up to 80 centres. The trial will compare clinical outcomes in patients who are treated with Abbott's investigational ZoMaxx drug-eluting coronary stent with patients who receive Boston Scientific's Taxus Express2 drug-eluting stent. The primary endpoint of ZOMAXX II is 9-month ischemia-driven target vessel revascularization, a clinical measure of the need to conduct another intervention (stent, brachytherapy or surgery) to reopen a vessel previously treated with a stent.
"Abbott is committed to develop the ZoMaxx drug-eluting stent as an important new treatment for coronary artery disease patients worldwide," said Robert B. Hance, president of Abbott Vascular, a division of Abbott. "The ZoMaxx drug-eluting stent is poised to become an important product in Abbott Vascular's growing line of vessel closure, coronary and endovascular products," he added.
The ZoMaxx drug-eluting stent consists of three key components: a flexible stent platform called TriMaxx designed to facilitate ease of placement; a unique polymer carrier called Pharmacoat intended to enable steady drug elution; and Abbott's patent-protected immunosuppressant drug called ABT-578, which has been shown to reduce vessel re-narrowing.