Apr 18, 2001
Guidant Announces European Approval and FDA Filing of MULTI-LINK PIXEL Coronary Stent System

New System Allows Physicians to Treat Wider Range of Coronary Blockages

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiovascular disease, today announced European CE Mark approval and market release of its MULTI-LINK PIXEL(tm) 2.0 mm Coronary Stent System, a new stent that will allow physicians to treat a wider range of coronary blockages. Guidant also announced that it has filed for approval of the MULTI-LINK PIXEL 2.0, 2.25 and 2.5 mm sizes with the U.S. Food and Drug Administration (FDA).

The CE Mark approval of the 2.0 mm diameter stent covers use for treating abrupt or threatened abrupt closures, which are arteries at risk of suddenly closing. This approval also will allow physicians to use the MULTI-LINK PIXEL's 2.25 and 2.5 mm sizes for treating abrupt or threatened abrupt closures. These two larger sizes received CE Mark approval in October 2000 and were previously only approved for use in treating first time coronary blockages.

The MULTI-LINK PIXEL was specifically designed for small vessels, which represent approximately 25 percent of the 1.5 million coronary interventions performed worldwide each year; traditional broad use coronary stent systems are designed for larger arteries. The MULTI-LINK PIXEL 2.0 mm is Guidant's smallest stent.

"Guidant is committed to providing physicians with a complete suite of products for treating patients with coronary artery disease," said John M. Capek, Ph.D., president, Vascular Intervention at Guidant. "We believe the addition of a new small vessel stent to our existing line of broad use and large vessel coronary stents will accomplish this goal, and we are pleased with initial physician feedback on the MULTI-LINK PIXEL."

"The latest results from randomized trials that compare balloon angioplasty with stent implantation in small vessels have demonstrated a reduction in restenosis and adverse clinical events in patients treated with a stent," said Eugolio Garcia, M.D., of Hospital Universitario Gregorio Maranon in Madrid, Spain. "The MULTI-LINK PIXEL is designed specifically for small vessels and performance of this system is among the highest from the available devices in Europe." Dr. Garcia has been involved in several clinical trials to study small vessel stenting, including serving as principal investigator for the Restenosis en Artérias Pequeñas (RAP) clinical trial.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.