Oct 11, 2002
Guidant Receives FDA Approval for its Next Generation Heart Failure Technology

Small, Physiologic-shaped CONTAK CD 2 System Combines Treatment for Both Heart Failure and Sudden Cardiac Death

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 that the U.S. Food and Drug Administration (FDA) has approved the CONTAK CD® 2 Cardiac Resynchronization Therapy Defibrillator (CRT-D) for the treatment of heart failure. The new CONTAK CD 2 system is smaller and lighter than any other CRT-D product currently available in the United States. It is physiologically shaped and, at 41 cc, is approximately 38 percent smaller than any competing CRT-D system in the United States.

"Since introduction, more than 7,000 heart failure patients worldwide have received the benefits of Guidant''s CRT-D therapy," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The CONTAK CD 2 is the second in a deep pipeline of U.S. CRT-D offerings from Guidant. We are pleased to provide this lifesaving and life-improving heart failure therapy system in a small, innovatively shaped design." Guidant expects to make the product available in the United States for the majority of the quarter.

Guidant was the first company to offer a device that combines cardiac resynchronization therapy with implantable defibrillation therapy, addressing the two primary concerns of physicians who treat heart failure patients'"improving their quality of life and protecting them from sudden cardiac death. Half of all heart failure deaths are a result of end-stage, progressive pump failure, and the other half are due to sudden cardiac death. The CRT function of the device helps the chambers of the heart beat in a coordinated manner, improving a heart failure patient''s functional capabilities. The implantable defibrillator function corrects potentially life-threatening rapid heart rhythms, preventing sudden cardiac death.

The new CONTAK CD 2 delivers therapy through Guidant''s innovative EASYTRAK® lead. The EASYTRAK lead, in conjunction with leads implanted in the right side of the heart, allows the CONTAK CD 2 pulse generator to sense and stimulate both the left and right sides of the heart. The EASYTRAK lead design was the first to allow physicians to position the electrode in a vein on the left side of the heart using a convenient over-the-wire technique similar to the system used in angioplasty procedures.

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.

Go to the Newsroom for photos of CONTAK CD 2.