Jul 13, 2001
Guidant Corporation Meets With the FDA on CONTAK CD/EASYTRAK System

Indianapolis, Ind. - Guidant Corporation (NYSE and PCX: GDT) and the U.S. Food and Drug Administration today met to identify next steps following the recent FDA Circulatory Systems Devices Advisory Panel vote for non-approval of Guidant's CONTAK CD(tm)/ EASYTRAK® System for the treatment of heart failure.

Based on the observations and questions of the panel, Guidant now believes that data and analysis can be quickly provided to address the needs of the FDA and the panel. Guidant intends to provide this further data and analysis to the FDA as early as July 20, 2001. The FDA has committed to work closely with Guidant to review this information and identify next steps.

"Our post-panel work and today's meeting give us renewed optimism. We are pleased that this device remains under an expedited review process," said Fred McCoy, president, Guidant Cardiac Rhythm Management. "Our commitment to the potential patient benefits of the therapy remains steadfast."

"We have fully dedicated the company to the required course of action to address the observations and concerns of the panel and the FDA," said Ronald W. Dollens, president and CEO of Guidant Corporation. "We are pleased to be able to report such quick progress on our work with the FDA."

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.