Mar 26, 2002
Guidant Provides Cardiac Rhythm Management New Product Update

Guidant Announces FDA Approval of INSIGNIA Advanced Pacemaker and Comments on Heart Failure Therapy Filing

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today provided a status update on its new cardiac rhythm management products. The company announced Food and Drug Administration (FDA) approval of its newest pacemaker platform-the INSIGNIA(tm) family of pacemakers. The company also indicated that FDA review of the CONTAK CD(tm)/EASYTRAK® system continues and is expected to be completed within the next several weeks. Consistent with the company's financial guidance, U.S. market availability of the CONTAK CD system is anticipated during a significant portion of the second quarter of 2002.

"There are currently no outstanding questions from the FDA to Guidant on this submission. We have had labeling and documentation discussions consistent with an advanced stage of review," commented Fred McCoy, president, Cardiac Rhythm Management, Guidant. "The filing remains on an expedited review path. As a result, the company is actively planning for physician training and other pre-launch activities."

In January, Guidant announced that a detailed agreement had been reached with the FDA that defines the regulatory path to approval for CONTAK CD in the United States. This path included the submission to the FDA of data on additional heart failure patients being treated with cardiac resynchronization therapy. The company provided that data in early February.

The company also received approval of its INSIGNIA pacing system, which represents Guidant's next pacemaker offering and features industry-leading therapies and patient management features.

"The INSIGNIA family of pacemakers represents a new generation of Guidant devices designed with ease-of-use in mind," said McCoy. "Full-scale launch will occur later in the second quarter of 2002. We anticipate that the INSIGNIA family's innovative feature-set and new shape will provide state-of-the-art technology to both patient and clinician."

The INSIGNIA pacing system's unique teardrop shape and smaller size give the device a more physiologic dimension intended to provide patient comfort and to facilitate its insertion during implantation. In addition to being smaller than previous Guidant pacemakers, this new platform offers improved longevity over its predecessors. The pacemaker also includes ease-of-use features that allow the clinician to easily and quickly perform a comprehensive set of patient follow-up tests.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 8 million 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.

This release includes forward-looking statements concerning the timing and outcome of the FDA's regulatory approval process. The statements are based on many important assumptions, including assumptions concerning the FDA's assessment of data submitted and internal FDA timelines and processes. As such, they involve risks and uncertainties that could cause actual results to differ materially. The company does not undertake to update its forward-looking statements.