A Medical Device Daily

The ZOMAXX II North American drug-eluting coronary stent clinical trial has commenced with the first enrolled patient, Abbott Vascular (Redwood City, California), a division of Abbott Laboratories (Abbott Park, Illinois), reported yesterday.

The initial procedure comes about one month after the company reported FDA approval of its investigational device exemption for the ZoMaxx drug-eluting stent (DES) system to treat coronary arteries (Medical Device Daily, April 8, 2005).

Jeffrey Moses, MD, of Lenox Hill Heart and Vascular Institute (New York), who performed the first trial procedure, said the stent was “highly deliverable” and had “enough flexibility to make it a compelling candidate for use in certain difficult-to-treat cases. ZoMaxx also is clearly visible under X-ray fluoroscopy, contributing to its ease of use and the ability to see its excellent scaffolding during and after stent implantation procedures.”

Lewis Schwartz, MD, divisional vice president of Abbott’s DES program, said that with initiation of the trial in North America, and ongoing enrollment in the ZOMAXX I trial internationally, the program “is poised to yield highly powered statistical comparisons with currently available treatments for occlusive coronary artery disease.”

ZOMAXX II is evaluating the safety and efficacy of the ZoMaxx DES compared to the Taxus Express2 DES, made by Boston Scientific (Natick, Massachusetts) to treat diseased coronary arteries that have an inadequate supply of blood to the heart muscle, otherwise known as ischemic heart disease.

Abbott describes ZOMAXX II as a 1,670-patient randomized trial at up to 80 North American centers. The primary endpoint is nine-month target vessel revascularization, a measure of the need to conduct another intervention to reopen a vessel previously treated with a stent.

The ZoMaxx DES system consists of three 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, named ABT-578, discovered and synthesized by Abbott scientists. Abbott said it is the first drug designed specifically for use with a DES.