Jul 17, 2001
Physicians Resume Implants with Guidant's ANCURE System

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, announced today that it has received an investigational device exemption from the U.S. Food and Drug Administration (FDA) that will allow implants to resume using Guidant's ANCURE® ENDOGRAFT® System. Several implants were performed yesterday, and additional implants are expected in the coming days. Guidant's ANCURE system is a minimally invasive method for repair of abdominal aortic aneurysm (AAA).

The clinical trial protocol allows Guidant's ANCURE system to be used to treat patients under informed consent at up to 300 hospitals with physicians already trained and with implant experience on the ANCURE system. The protocol also requires collection of delivery system performance data during the implant procedure, as well as 30-day patient follow-up.

"We are pleased with the FDA's willingness to work with Guidant to resume implants of ANCURE," said Guidant Corporation's Beverly Huss, president, Endovascular Solutions. "We believe strongly in the patient benefits of treatment with the ANCURE system and we look forward to getting this important therapy back into the hands of physicians."

In March 2001, Guidant initiated a voluntary recall of the ANCURE system based on deficiencies the company identified in regulatory processes and communications with the FDA. Guidant subsequently filed ANCURE-related PMA supplements and a corrective action plan with the FDA; these documents are under review.

"Guidant is continuing to work closely and constructively with the FDA to return the ANCURE System to market as soon as possible," added Huss. "We have resumed ANCURE implants this week and we are also preparing for full market release in the fourth quarter pending FDA approval."

About AAA and the ANCURE System

Abdominal aortic aneurysm is an enlargement of the aorta - the largest blood vessel in the human body - that results from a weakening of the vessel wall. If left untreated, the enlargement can lead to rupture of the aorta, which is fatal in nearly 80 percent of cases. Approximately 200,000 new cases of AAA are diagnosed each year in the United States.

The traditional method for repairing AAA is a major surgical procedure that requires a long incision down the patient's chest and abdomen. Recovering from this procedure often involves a hospital stay of approximately one week, as well as several months of convalescence to fully recover. Endovascular repair of AAA using the ANCURE system is a minimally invasive procedure that requires small incisions in the patient's groin, into which the catheter-based ANCURE delivery system is inserted. The delivery system, carrying the ANCURE ENDOGRAFT is delivered to the site of the aneurysm, where the ENDOGRAFT is secured in place to bypass the aneurysm.

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.

This release contains forward-looking statements about the company's future financial results, the company's prospects and products in research and development. This information is based upon management's current expectations, but actual results may differ materially from those discussed in the forward-looking statements. Other factors affecting future results include those outlined in Exhibit 99.1 to the company's Form 10-K for the quarter ending March 31, 2001.