Jul 1, 2005
FDA Classifies Prior Guidant Recalls
Guidant Reiterates its Previous Physician and Patient Recommendations Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) said today that FDA has classified its June 17, 2005 and June 24, 2005 physician communications regarding certain devices. FDA has designated as "Class I" the previously announced physician communications concerning: A "Class I" recall is the highest priority recall. This recall, which consisted of a letter to physicians and patients, was sent out on June 17. A Class I recall is one in which there is a reasonable probability that, if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death. FDA has designated as "Class II" the previously announced physician communications concerning: A Class II recall is one in which the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote. These recall classifications do not affect Guidant''s current recommendation to physicians and patients. Guidant recommends that physicians continue with normal follow-up patient visits at three-month intervals. Neither Guidant nor FDA is making a recommendation as to whether individual patients should have their devices removed. Rather, both believe that decision is best made by consultation between patients and their physicians, based on the specific case history of each patient. In certain cases, the risks associated with the surgery to explant the device will outweigh the extremely small risk of device malfunction. Guidant believes FDA''s classification will assist in its efforts to ensure that doctors and patients receive the necessary information to determine patient care. "The health and safety of patients is paramount," stated Ronald W. Dollens, president and CEO, Guidant Corporation. "Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients." 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 has worked closely with FDA since the announcement of the physician communications, and has made FDA aware of all Guidant statements set forth in prior press releases, physician communications, and patient letters on this matter. Furthermore, FDA has acknowledged Guidant''s efforts in communicating important safety information. Guidant will continue to work to meet and exceed the expectations of physicians, patients 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, including the Food and Drug Administration, patient advocates, and physician societies. For additional current information regarding expert and independent physician recommendations regarding response to device recalls, see the recent "Heart Rhythm Society Advisory Regarding Recalls for ICD''s" at http://www.hrsonline.org/swAdvocacyFiles/advocacy103020093.asp. Additional information about the recalls is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://guidant.com/patient/communication. 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.