Aug 6, 2002
Guidant Announces FDA Approval of Newest Active-Fixation Defibrillation Lead

Defibrillation Lead Features Advances in Ease of Handling and Positioning

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced U.S. Food and Drug Administration (FDA) approval of the ENDOTAK RELIANCE® active-fixation defibrillation lead. This top-tier lead, backed by a limited lifetime warranty, completes the ENDOTAK RELIANCE family and will be market released later this month.

"The new RELIANCE active-fixation lead will provide our physician-customers with exciting new ease-of-use features and time-tested lead technology. We back RELIANCE with a lifetime warranty," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "This premium lead is a great addition to our strong implantable defibrillator lineup."

Endocardial defibrillation leads are thin, insulated wires that connect an implantable cardioverter defibrillator (ICD) to the heart. The lead transmits signals from the heart to the ICD device and, when appropriate, delivers therapy from the ICD back to the heart. All ENDOTAK RELIANCE leads feature a thin, smooth isodiametric body. A simplified fixation mechanism allows the helix-shaped tip to be deployed smoothly into the heart wall. New fluoroscopic markers enable clinicians to clearly see the helix extending into the tissue. Combined with a VENTAK® PRIZM® 2 implantable defibrillator, the VENTAK PRIZM 2/ENDOTAK RELIANCE system provides a small, thin, full-featured system for the treatment of dangerous or irregular heart rhythms.

"The small size and excellent handling characteristics of this new lead made it easy to implant," said Dr. Timothy Shinn, investigator in the ENDOTAK RELIANCE active-fixation lead clinical study at St. Joseph Mercy Hospital, Ann Arbor, Mich. "These features, coupled with Guidant''s established reliability in lead technology, result in an outstanding defibrillation lead."

Guidant Corporation pioneers lifesaving technology, giving an opportunity for 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.