Jul 22, 2005
Guidant Updates Corrective Actions Regarding Its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT Implantable Cardiac Defibrillators

Guidant Updates Corrective Actions Regarding Its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT Implantable Cardiac Defibrillators

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) said today it is updating previous safety information regarding its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT devices. FDA may consider this action a recall. This update revises the original recommendations set forth in Guidant''s June 17, 2005 letter to physicians because new information indicates that one of the original recommendations can significantly increase the risk to patients. Physicians should use this information to decide how best to treat their patients.

As described in the June 17, 2005 letter, Guidant has determined that the atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to latching where the device can lock up and thus affect available therapy. At that time, two occurrences had been confirmed out of approximately 20,950 devices implanted to date. As a result, one of Guidant''s recommendations was to make a programming change to the device.

On July 11, 2005, a third latching event was reported in the United States. Guidant immediately began analysis and has determined that this event occurred despite the recommended device programming change. This third event, similar to the first two events, resulted in no apparent patient injury beyond device replacement. Additional events, including a possible injury, are being evaluated.

Based on study of the recent third event, Guidant has determined that one of our original recommendations can cause a significantly higher probability of occurrence of latching for certain devices. For this reason, Guidant has changed its programming recommendation, and communicated this change today to physicians who have patients with affected devices.

In addition, Guidant is currently developing a non-invasive software solution for VITALITY AVT and all RENEWAL AVT devices. This solution may be available in early fourth quarter, pending regulatory approval.

The actions taken by the company over the last several weeks reflect our commitment to provide more timely information to physicians and patients about our devices. Guidant will continue to work to meet and exceed the expectations of patients, physicians, and FDA.

Guidant recently announced its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices. Guidant plans to cooperate with and enlist the support of other interested parties.

Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and www.guidant.com/physician_communications/AVT_2.pdf.

This release includes forward-looking statements concerning the course of developments with respect to the affected products. These statements are based on assumptions about many important factors, including continuing developments with respect adverse event rates, regulatory agency actions, and other factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.