First Patient in Clinical Trial of The Zomaxx Drug-Eluting Coronary Stent

Main Category: Cardiovascular / Cardiology
Article Date: 15 Sep 2004 - 14:00 PDT

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Abbott Vascular Devices, a division of Abbott Laboratories, announced today the enrollment of the first patient in the ZOMAXX I drug-eluting coronary stent clinical trial.

ZOMAXX I is a 400-patient prospective randomized clinical trial that will be conducted in more than 30 centers in Europe, Australia and New Zealand. The study compares Abbott's ZoMaxx™ drug-eluting coronary stent to Boston Scientific's Taxus™ Express2™ drug-eluting stent with a primary endpoint of 9-month in-segment late loss (a measurement of the re-narrowing of the vessel). Enrollment is expected to continue through the first quarter of 2005.

"The initiation of the ZOMAXX I clinical trial represents a significant milestone for our organization," said Robert B. Hance, president, Abbott Vascular Devices. "Along with our plans for a North American pivotal trial, the start of ZOMAXX I demonstrates our commitment to becoming a leading player in drug-eluting stents, one of the fastest growing areas in medical technology."

Robert Whitbourn, M.D., of St. Vincent's Hospital in Melbourne, Australia, enrolled the first patient in the ZOMAXX I trial. "I am looking forward to enrolling additional patients in this important trial. Based on in vitro studies, the ZoMaxx stent design demonstrated excellent flexibility, contributing to a high level of deliverability. I am eager to test the device clinically," said Dr. Whitbourn.

The ZoMaxx Drug-Eluting Coronary Stent

The ZoMaxx stent used in this study consists of three key components: the drug, the stent platform and the polymer carrier. The drug, ABT-578, is a patent-protected immunosuppressant discovered and synthesized by Abbott scientists. It inhibits inflammation and proliferation of smooth muscle cells, both key targets in treating restenosis (the re-narrowing of the artery after an interventional procedure). In animal testing, when compared to similar compounds, ABT-578 has been shown to be highly lipophilic (allowing a greater concentration of drug to penetrate the tissue).

The second key component for ZoMaxx is the underlying stent platform - the TriMaxx™ Coronary Stent, which is currently under CE Mark review as a non-drug eluting stent. The TriMaxx stent is anticipated to be the next evolution in metallic stents with its unique tri-layer composite of stainless steel and tantalum, and its ultra-low crossing profile - designed to facilitate placement of the stent in the artery. This tri-layer composite material allows for extremely thin struts (mesh scaffolding) while maintaining optimal visibility via angiography (a form of X-ray). The TriMaxx stent also utilizes a novel stent pattern with Apex Ring Control (A.R.C.™), which is designed to maximize flexibility and deliverability while maintaining ideal scaffolding and vessel wall coverage for uniform drug delivery.

Alexandre Abizaid, M.D., of Dante Pazzanese Hospital in São Paulo, Brazil, conducted the first clinical implants of the TriMaxx Coronary Stent in May 2004. "I was impressed with the very low profile and exceptional deliverability of the TriMaxx stent," said Dr. Abizaid. "Even with such thin struts, it was still clearly visible via angiography during the procedure, allowing me to place the stent with precision."

The third key component of the ZoMaxx stent is Pharmacoat™, a unique formulation of phosphorylcholine polymer coating licensed to Abbott from Biocompatibles International plc. Phosphorylcholine is a polymeric replica of the outer surface of a red blood cell that acts as a biologically inert coating that resists clot formation in vitro. Pharmacoat is a specific formulation of phosphorylcholine that contains an extra cap-coat - an additional layer of coating that enables the drug to elute over time. In vitro studies show that Pharmacoat acts as a versatile drug-eluting vehicle that provides a stable foundation for the slow, controlled release of ABT-578. Since 1996, 150,000 non-drug eluting phosphorylcholine-coated stents have been implanted worldwide.

The principal investigator of ZOMAXX I, Bernard Chevalier, M.D., of Centre Cardiologique Nord, near Paris, France, said, "I am delighted to be associated with this important clinical study. Abbott Vascular Devices has worked to optimize all of the key components in its drug-eluting stent technology. The drug, ABT-578, is a promising compound in the battle against restenosis, and the phosphorylcholine polymer, Pharmacoat, is formulated to provide a slow, controlled release of the drug. By randomizing against Taxus, the ZOMAXX I trial will demonstrate the performance of the ZoMaxx stent."

About Abbott Vascular Devices

Abbott Vascular Devices, Abbott's cardiovascular franchise headquartered in Redwood City, California, is a medical technology pioneer that combines its entrepreneurial spirit and medical device expertise with Abbott's pharmaceutical heritage to deliver specialized treatment options that are designed to improve the care of people with cardiovascular disease. Abbott Vascular Devices brings the best of these backgrounds together to develop unique products that address the specialized needs of cardiovascular disease treatment through three main business units: Vessel Closure Technologies, Coronary Technologies and Endovascular Technologies.

About Abbott Laboratories

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 55,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Taxus is a trademark of Boston Scientific Corporation.
ZoMaxx, TriMaxx, Pharmacoat and A.R.C. are trademarks of Abbott Laboratories.

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