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Steven Tragash
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FOR IMMEDIATE RELEASE -- Indianapolis, IN -- July 18, 2005 -- Guidant Corporation (NYSE:GDT) said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.
A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted:
These products, which are of an earlier generation design, have not been sold or implanted for the last four years.
Guidant has determined that a hermetic sealing component used in the subset of devices listed above may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.
As of July 11, 2005, Guidant has identified sixty-nine (69) devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time. Guidant's modeling based on field experience and statistical life-table analysis predicts the rate of failure in the remaining active implanted devices to be between 0.17% and 0.51% over the remaining device lifetime. Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide; 18,000 of these devices remain in service in the United States with an average implant age of 69 months.
It is Guidant's recommendation to physicians that they consider the unique needs of individual patients and the specific technical recommendations set forth in Guidant's physician communication, dated July 18, 2005. In addition, Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients. In addition, Guidant advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.
The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Additionally, Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died. It is unknown if this device experienced the failure described above as the device was not returned and this failure mode could not be confirmed.
Many of these devices are nearing or have exceeded their estimated longevity and have thus outlived their warranty. Guidant will provide a replacement device at no charge for pacemaker-dependent patients and other patients deemed by their physicians to be best served by replacement, provided the replacement occurs prior to the normal appearance of elective replacement indicators. This supplemental warranty program is available through December 31, 2005. Additionally, Guidant will reimburse patients up to $2,500 for medical expenses remaining after Medicare and/or health insurance coverage, including device replacement or additional follow-up procedures.
"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. 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.
Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/PDM.pdf.
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