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Guidant Announces Enrollment of First Patient in Clinical Trial of the World's First Fully Bioabsorbable Drug Eluting Coronary Stent; Innovative Technology Could Represent New Frontier in the Treatment of Heart Disease.


INDIANAPOLIS & SANTA CLARA, Calif. -- Guidant Corporation (NYSE NYSE

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) today announced enrollment of the first patient in a first-in-man clinical trial designed to evaluate the safety of a fully bioabsorbable everolimus eluting stent platform for the treatment of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . The trial, called ABSORB, will enroll up to 60 patients in Belgium, Denmark, France, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , Poland and The Netherlands.

"As the world's first clinical trial evaluating a fully bioabsorbable drug eluting coronary stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent , this initial implant marks a significant milestone for Guidant. This study will lay the foundation for our continued work toward offering a valuable alternative to current drug eluting stent implants that reside permanently in the treated coronary artery coronary artery
n.
1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and
," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "We are excited about our bioabsorbable drug eluting stent program, which is aligned with Guidant's strategy of leveraging bioabsorbable technologies to provide innovative site-specific therapy for the treatment of heart disease."

The ABSORB trial will study the safety of bioabsorbable drug eluting stents developed by Bioabsorbable Vascular Solutions, an entrepreneurial subsidiary of Guidant Vascular Intervention established in 2003 in the Silicon Valley. These stents are designed to be fully absorbed by vascular tissue following the restoration of blood flow and drug elution elution /elu·tion/ (e-loo´shun) in chemistry, separation of material by washing; the process of pulverizing substances and mixing them with water in order to separate the heavier constituents, which settle out in solution, from the  in patients with coronary artery disease. Guidant has completed extensive preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 on its bioabsorbable stent, gathering data on safety, drug dosing, and the mechanical properties of the stent. The ABSORB clinical trial is a non-randomized study with an initial assessment of safety (MACE and stent thrombosis rate) at six months and a follow-up period of five years.

The first implant was performed by a team headed by Drs. John Ormiston and Mark Webster at Auckland City Hospital The Auckland City Hospital is Auckland's main hospital and the largest hospital in New Zealand,[1] as well as one of the oldest medical facilities of the country. It is a publically funded hospital, run by the Auckland District Health Board since 2001. , New Zealand. Dr. Ormiston and Professor Patrick Serruys, of the Thoraxcenter, Erasmus University Hospital, Rotterdam will serve as the study's co-principal investigators.

"With patients receiving an ever-increasing number of coronary stents in more challenging vessel anatomies, we need clinical solutions that reduce the amount of permanent metallic stent platforms being implanted, and provide for increased flexibility in monitoring and treating patients over an extended period of time," said Dr. Ormiston. "We are highly encouraged by the progress thus far with Guidant's bioabsorbable technology, and look forward to further exploring its potential as part of the ABSORB trial."

Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Guidant develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom.

This release includes forward-looking statements. The statements are based on assumptions about many important factors, including the company's expectations concerning the clinical data that will result from the trial, and other factors identified in Item 1A of the company's most recent filing on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
. Actual results may differ materially. The company does not undertake to update its forward-looking statements.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 9, 2006
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