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Abbott Enrolls First Patient in Pivotal
Drug-Eluting Stent Clinical Trial ZoMaxx™ Drug-Eluting Stent System, Designed for Optimal Visibility and Deliverability, Is Under Investigation to Treat Patients with Coronary Artery Disease ABBOTT PARK, Ill., May 17 -- Abbott today announced enrollment of the first patient into its ZOMAXX II North American drug-eluting coronary stent clinical trial. The announcement comes just one month after the company announced the U.S. Food and Drug Administration had approved its Investigational Device Exemption (IDE) application for the ZoMaxx drug-eluting coronary artery stent system. "I found the ZoMaxx stent to be highly deliverable. It performed superbly during the procedure and appears to have enough flexibility to make it a compelling candidate for use in certain difficult-to-treat cases," said Jeffrey W. Moses, M.D., who performed the first interventional procedure in the ZOMAXX II trial. "ZoMaxx is also 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." "With the initiation of ZOMAXX II in North America, and ongoing enrollment in the ZOMAXX I trial internationally, Abbott's drug-eluting stent program is poised to yield highly powered statistical comparisons with currently available treatments for occlusive coronary artery disease," said Lewis B. Schwartz, M.D., divisional vice president of Abbott's drug-eluting stent program. ZOMAXX II will evaluate the safety and efficacy of Abbott's investigational ZoMaxx drug-eluting stent system in comparison to Boston Scientific's Taxus™ Express2™ drug-eluting stent in patients with diseased coronary arteries who have an inadequate supply of blood to the heart muscle (ischemic heart disease). "Abbott has launched a comprehensive clinical plan to bring the ZoMaxx drug-eluting stent system to market. Together, the ZOMAXX I and II trials will generate a robust data set with both clinical and angiographic endpoints that will provide a substantial basis on which to evaluate the safety and efficacy of ZoMaxx," said Alan Yeung, M.D., interventional cardiology professor of medicine and director of the Cardiac Catheterization and Coronary Intervention Laboratories at Stanford University Medical Center and principal investigator in the ZOMAXX II trial. William Gray, M.D., associate professor of medicine and director of endovascular intervention at the Center for Intervention and Vascular Therapy at Columbia University in New York City, is co-principal investigator in the trial. About the ZOMAXX II Clinical Trial ZOMAXX II is a 1670-patient prospective randomized trial that will be conducted in up to 80 centers across North America. The primary endpoint of ZOMAXX II is 9-month 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. About The ZoMaxx Drug-Eluting Stent System The ZoMaxx drug-eluting stent system 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. The TriMaxx Coronary Stent has extremely thin struts (mesh scaffolding) and an ultra-low crossing profile designed to facilitate stent placement in arteries. TriMaxx is the first and only stent platform developed with a tri- layer composite of stainless steel and tantalum designed to enable optimal visibility under X-ray fluoroscopy. The application of biologically inert Pharmacoat to the ZoMaxx stent is designed to allow a measured elution of ABT-578 over time. Pharmacoat is a unique formulation of phosphorylcholine licensed to Abbott from Biocompatibles International plc. ABT-578 was discovered and synthesized by Abbott scientists and is the first drug designed specifically for a drug-eluting stent. Studies have shown that ABT-578 inhibits inflammation and the proliferation of smooth muscle cells that can lead to artery re-narrowing following interventional procedures. About Coronary Artery Disease Coronary artery disease, also called ischemic heart disease, is the leading cause of chest pain, heart attack and sudden death. The American Heart Association estimates that 6.4 million Americans have experienced chest pain, over 7 million have suffered a heart attack and 13 million people have coronary artery disease. Coronary artery disease is caused by the accumulation of fat, cholesterol and other deposits in the artery that supplies blood to the heart, through the coronary arteries. It is a precursor to angina, or chest pain, which is a warning sign of heart attack. Until the early 1980's, one of the only options for patients with advanced coronary artery disease was coronary artery bypass surgery (CABG), but with the advent of interventional treatments like angioplasty and stent implantation, physicians now have less invasive options for treating patients with coronary artery disease. Stents are tiny metal scaffolds placed in diseased arteries to keep them open and re-establish blood flow. Drug-eluting stents, or stents that release drugs into blood vessel walls, have been shown to increase the long-term favorable effects of treating diseased arteries with stents. About Abbott Vascular Abbott Vascular, a division of Abbott, is transforming the treatment of vascular disease, combining the latest medical device innovations with world- class pharmaceuticals to advance medicine and improve patient care. Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, ease of use and effectiveness in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information about Abbott Vascular, visit http://www.abbottvascular.com . ZoMaxx is not available for sale in the United States. ZoMaxx is an investigational device, limited by Federal law to investigational use. About Abbott Abbott (NYSE: ABT - News) 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 more than 60,000 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 and Pharmacoat are trademarks of Abbott. source: Abbott |
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