Abbott (ticker: ABT, exchange: New York Stock Exchange (.N))
News Release -
Abbott Enrolls First Patient in Pivotal Drug-Eluting Stent Clinical Trial
ZoMaxx(TM) Drug-Eluting Stent System, Designed for Optimal Visibility and
Deliverability, Is Under Investigation to Treat Patients with Coronary Artery
ABBOTT PARK, Ill., May 17 /PRNewswire-FirstCall/ -- 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
ZOMAXX II will evaluate the safety and efficacy of Abbott's
investigational ZoMaxx drug-eluting stent system in comparison to Boston
Scientific's Taxus(TM) Express2(TM) 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
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(TM) designed to facilitate ease of
placement; a unique polymer carrier called Pharmacoat(TM) 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
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
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.
Abbott (NYSE: ABT) 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
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.
/CONTACT: Media, Karin Bauer Aranaz, +1-353-879-885973, or Financial
Community, John Thomas, +1-847-938-2655, both of Abbott/
/Company News On-Call: http://www.prnewswire.com/comp/121546.html/
/Web site: http://www.abbott.com
CO: Abbott; Abbott Vascular
IN: MTC HEA BIO
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1224 05/17/2005 08:52 EDT http://www.prnewswire.com