Sep 22, 2005
Guidant Announces Completion of FDA Inspection of St. Paul Facilities and Responds to FDA's Observations

Indianapolis, Ind. - Guidant announced today that the U.S. Food and Drug Administration (FDA) has completed its inspection of Guidant's Cardiac Rhythm Management facilities in St. Paul, Minnesota, and has provided Guidant a Form 483, noting several observations of non-compliance, including an observation with commentary on two specific trends in its INSIGNIA® and NEXUS® families of pacemakers.

Guidant has provided the FDA with a thorough written response to the observations, describing the steps that Guidant has taken and will be taking to address the FDA''s observations. In connection with its response, Guidant is issuing a physician communication on two specific trends in its INSIGNIA and NEXUS families of pacemakers. A copy of the physician communication can be found at www.guidant.com/physician_communications/insignia-nexus.pdf.

Guidant has taken action to increase the flow of information to physicians and patients on device performance. Recently, Guidant Cardiac Rhythm Management (CRM) published its 2005 Product Performance Report, which may be reviewed at www.guidant.com/physician/product_performance_report.pdf. This report includes more specific information than was contained in past such reports. A further enhancement to this report is planned by the end of the year.

In addition, Guidant has now provided physicians with Advisory Updates on its PRIZM® 2 DR and CONTAK RENEWAL® and RENEWAL 2 devices which were subject to Physician Advisories previously communicated in June. The Advisory Updates include updated rate of occurrence information and results from returned product testing. The Advisory Updates may be found at www.guidant.com/physician_communications.

"Our efforts to provide product performance information in increasing quantity and frequency to physicians and patients is well-underway," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "We will work closely with physicians, patients, the Heart Rhythm Society (HRS) and other industry participants and stakeholders on the broad issues highlighted at the recent HRS Policy Conference on Pacemaker and ICD Performance."

Guidant recently announced the formation of an Independent Panel, chaired by Dr. Robert J. Myerburg, Professor of Medicine and Physiology at the University of Miami, to report on ways that Guidant can further enhance capabilities in understanding, detecting and disseminating important product performance information. In addition, the Panel will make public its non-proprietary observations and recommendations regarding these issues that may be useful to others in the device industry, regulatory bodies, and clinical community. The Panel held its first meeting last month. The Panel''s goal is to present its complete report within six months.

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 12,000 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.