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Guidant Receives CE Mark Approval for the MULTI-LINK VISION Cobalt Chromium Coronary Stent System; New Technology Demonstrates Excellent Clinical Results
Business Wire, Dec 19, 2002
Business Editors, Health & Medical Writers
INDIANAPOLIS & BRUSSELS--(BUSINESS WIRE)--Dec. 19, 2002
Guidant Corporation (NYSE:GDT)(PCX:GDT), a world leader in the treatment of cardiac and vascular disease, today announced that the company has received Conformite Europeenne (CE) Mark approval for the MULTI-LINK VISION(TM) Coronary Stent System, the company's first cobalt chromium stent platform for the treatment of coronary artery disease. The MULTI-LINK VISION Coronary Stent System's cobalt chromium alloy provides excellent radial strength and visibility and allows the stent to have thin stent struts and superb deliverability.
"The MULTI-LINK VISION Stent System pioneers an innovative new class of Guidant stents powered to perform with low nickel content cobalt chromium, an alloy that sets a new standard for value in stent design technology," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The stent is designed with thin struts and has shown excellent clinical results, with a nine-month clinically-driven target lesion revascularization rate of 6.2 percent. We are very pleased that Guidant's breakthrough MULTI-LINK VISION Stent System is now available to European patients and physicians."
Guidant plans to use cobalt chromium stents in future stent and drug eluting stent platforms. The company expects to introduce a small-vessel cobalt chromium stent in Europe in the second quarter of 2003.
"The clinical results from the first MULTI-LINK VISION Stent System registry are extremely promising. The MULTI-LINK VISION Stent has excellent procedural performance and outcome characteristics," said Dr. Dean Kereiakes, principal investigator for the study, CEO, Ohio Heart Health Center, and medical director of The Lindner Center for Research & Education, at The Christ Hospital in Cincinnati.
Due to the MULTI-LINK VISION Stent System's excellent clinical results and performance characteristics, Guidant's cobalt chromium stent will be priced at a premium to stainless steel metal stents currently on the market.
Since 1995, Guidant has set high standards in stent design. Guidant offers a family of stents designed to meet individual vessel needs. The company recently launched its sixth-generation stainless steel stent, the MULTI-LINK ZETA(TM) Coronary Stent System, which contains many technological advancements in deliverability. Guidant's MULTI-LINK PIXEL(TM) System, designed specifically for small vessels in patients presenting with abrupt or threatened abrupt closure, and MULTI-LINK ULTRA(TM) System, designed for large vessels, complete the company's product line for the treatment of coronary artery disease. More than three and a half million patients have benefited from Guidant stent technology since the launch of Guidant's first coronary stent system.
Guidant Corporation pioneers lifesaving technology, giving an opportunity for a better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, 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.
This release includes forward-looking statements concerning product development for the VISION stent. The statements are based on assumptions about many important factors, including regulatory timelines and approvals, continuing clinical and other developments, and other factors identified on Exhibit 99.1 to the company's most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.
NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom.
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