Jul 9, 2001
Guidant Receives FDA Approval of First Stent Designed Exclusively for Small Vessels in Patients Presenting with Abrupt and Threatened Abrupt Closure

Stent's Performance in Europe Supports Growth in Guidant's Stent Market Position

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval of the first stent available in the U.S. designed specifically for small coronary arteries in patients that present with abrupt or threatened abrupt closure due to unsuccessful interventional therapy. The system is approved in de novo (first time) and restenotic (re-occurring) native coronary artery lesions.

"With industry statistics indicating that approximately one in four patients with coronary artery disease have small vessel disease, Guidant designed the first stent specifically for small vessels in patients presenting with abrupt or threatened abrupt closure of these arteries," said Guidant Corporation's John M. Capek, Ph.D., president, vascular intervention. "Introducing the MULTI-LINK PIXEL to help treat a very prevalent type of coronary artery disease fits with Guidant's strategy of augmenting our existing line of broad use coronary stent systems with lesion-specific stents designed for particular types of coronary artery disease."

Adoption of the MULTI-LINK PIXEL Brisk in Europe

"Guidant launched the MULTI-LINK PIXEL Stent in Europe earlier this year, and we have been extremely pleased by the response we have received from the European market," said Guido J. Neels, president, Guidant Europe, Middle East, Africa and Canada.

During the first quarter of this year, the MULTI-LINK PIXEL(tm) Coronary Stent System fuelled an average 23 percent increase in Guidant's total stent unit sales to hospitals in Europe where it was available, indicating a growth in Guidant's stent market share position and growth in the use of stenting in small vessels (2.0 mm to 2.5 mm in diameter).

About the MULTI-LINK PIXEL Coronary Stent System

Guidant designed the MULTI-LINK PIXEL System with small vessels in mind, incorporating technology to help physicians better treat coronary artery disease in small diameter arteries. The MULTI-LINK PIXEL Stent is constructed of less metal than traditional broad use coronary stents, making it the lowest profile system available in the U.S. The low profile stent delivery system is specifically designed to deliver to small vessels.

"Cases that involve small vessel disease are very challenging due to the distal location of the vessels and the possibility that an abrupt closure may occur," said David A. Cox, M.D., of the Presbyterian Hospital in Charlotte, N.C., who also served as principal investigator of Guidant's MULTI-LINK PIXEL Registry. "The excellent deliverability of Guidant's MULTI-LINK PIXEL Stent provides physicians with an immediate, minimally invasive way of treating blockages in small diameter vessels."

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.