GDT Guidant Corp

Guidant Corporation (NYSE:GDT) announced today the easy availability of even more detailed product performance information for its cardiac rhythm management (CRM) products. "We understand that patients, physicians and others are requesting additional information related to product performance," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "Our updated CRM Product Performance Report delivers an unprecedented level of relevant product performance information in a single, readily-accessible report." As part of its Quality System, the Company continually collects and analyzes information about product performance through field observations and other quality metrics. Analysis is performed on all returned products and complaints. These efforts are taken to better understand product performance and results in the identification of patterns of failure in its marketed devices, even those that occur at very low frequency. The Company uses this learning to continually improve manufactured products and shares this learning with product development teams to improve the performance of subsequent product generations. Guidant also communicates information concerning product performance to various stakeholders including regulatory bodies and physicians. Today, Guidant published the following: -- An updated CRM Product Performance Report that provides confirmed failure details by product family. This information contains descriptions of clinical manifestations and causes for patterns of failures. Additionally, device failures are further characterized to describe therapy availability. The updated Product Performance Report can be found at http://www.Guidant.com/physician/ppr/. "We take this action as we continue to work with the Heart Rhythm Society and other stakeholders toward the establishment of industry-wide communication standards," added Dr. Joseph Smith, chief medical officer, Cardiac Rhythm Management, Guidant Corporation. "We also look forward to the recommendations of the Independent Panel convened by Guidant to advise the firm on the enhancement of surveillance and communication regarding safety and performance of our devices." "I greatly support this concept of detailed disclosure and transparency," said Eric N. Prystowsky, M.D., director, Clinical Electrophysiology Lab, St. Vincent Hospital, Indianapolis. "It is where the entire industry needs to go." Dr. Prystowsky is a member of the Heart Rhythm Society Task Force currently drafting public policy recommendations to improve the pacemaker and implantable cardioverter defibrillator post-market surveillance system and related communications between device manufacturers, the federal government, clinicians and patients. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The Company 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.