Independent Panel Commissioned by Guidant Issues Report and Recommendations

Panel Chaired by Internationally Recognized Electrophysiologist Dr. Robert J. Myerburg Offers In-Depth Analyses and Eight Major Recommendations to the Corporation 


MIAMI, March 21  /PRNewswire-FirstCall/ -- The Independent Panel convened in August 2005 by Dr. Robert J. Myerburg at the request of Guidant Corporation (NYSE:GDT) issued its Report on findings and recommendations regarding surveillance and communications surrounding the performance of life-sustaining implantable devices.  The Panel was chaired by Dr. Myerburg, Professor of Medicine and Physiology at the University of Miami, who recruited the 11 other panel members, each a distinguished expert in his or her field of endeavor. The Report was presented yesterday to the Chief Executive Officer and Board of Directors of Guidant Corporation.

Dr. Myerburg stated, "From the outset, the Panel members were determined that the analysis and recommendations in the Report would be neither a whitewash nor a witch hunt, but rather a search for, and honest appraisal of, the facts.  Our intent was to develop recommendations that would provide a true benefit to those who receive implantable cardiac devices, to Guidant Corporation, and to others that manufacture these devices.  Each Panel member worked hard to review and analyze these complex issues, and we benefited from the diversity of backgrounds and expertise of the various Panel members.  In addition, Guidant Corporation honored its commitment to the Panel to provide unfettered access to corporate records and personnel, and to respect the independence of our deliberations.  The result is a product that we believe will help Guidant resolve the problems that emerged during the past year. These recommendations also may also be useful to others in the industry - to the ultimate benefit of patients and physicians. We are pleased that Guidant has embraced the Report's approach to improving the transparency and the communication process between device manufacturers and physicians and patients, and is making the entire report available to the public.

Panel member Dr. David W. Feigal, Research Professor of the Arizona Biodesign Center at Arizona State University, and Past Director of the Center for Devices and Radiologic Health at the Food and Drug Administration, commented, "We should not lose sight of the fact that these devices already perform at a very high level of reliability and provide great benefit. Guidant asked the panel to make recommendations to deal with special circumstances where low frequency failures need to be communicated so that doctors and patients can make informed decisions about care. The challenges posed by such circumstances are not unique to Guidant; every manufacturer faces the same kind of problems."

  The Panel made the following major recommendations to Guidant:

  1.  Establish an external committee of experts to serve as advisors to
      Guidant regarding evaluation of product performance and health risk
      assessment, potential actions to be taken in regard to device failures
      and malfunctions, and guidance on when and how to communicate with
      physicians and patients.

  2.  Designate or hire an in-house physician whose primary responsibility
      is patient safety and who will participate in product performance
      analysis, health hazard analysis, internal communications and external
      communication policies and procedures.

  3.  Strengthen management links between the Corporation and its CRM
      business unit, with specific attention to post-market product
      performance, patient safety issues and communication policies.

  4.  Enforce the general policy of the CRM business on the primacy of
      patient safety by better integrating patient safety concerns into the
      factual and statistical analysis of product performance and
      performance failures.

  5.  Ensure that the CRM business, and the Company generally, implement and
      enforce policies of transparency of information regarding product
      performance and health hazard risk both to physicians and the general
      public as new information is emerging.

  6.  Develop processes for confronting the challenge of achieving more
      effective surveillance of marketed devices, in conjunction with others
      in the industry, the Heart Rhythm Society, and the FDA.

  7.  In addition to the analysis of product performance and safety event
      trends, develop processes to identify and act on even a single event
      when it is associated with risk of death or serious injury, has a
      suspected or defined basis for the malfunction or failure, and is
      likely to be systematic and to occur in other patients.

  8.  When a life-threatening defect has been identified and mitigated in a
      specific product line, Guidant Corporation and its CRM business should
      expedite review for immediate consideration of ceasing shipments of
      unmitigated devices, and retrieving those in possession of the sales
      force or in hospital inventories.



In addition to Dr. Myerburg and Dr. Feigal, the Panel members included: George E. Apostolakis, Ph.D., Professor of Nuclear Science and Engineering and Professor of Engineering Systems at Massachusetts Institute of Technology; George A. Beller, M.D., MACC, FAHA, Professor of Cardiology at University of Virginia Health System and Past President, American College of Cardiology; John P. DiMarco, M.D., Ph.D., FACC, FAHA, Professor of Medicine at University of Virginia Health System; Kenneth Goodman, Ph.D., Associate Professor of Medicine and Philosophy and Director of the Bioethics Program in the University of Miami Ethics Program; Sharon A. Hunt, M.D., FACC, Professor of Medicine at Stanford University School of Medicine; Bruce D. Lindsay, M.D., FACC, Associate Professor of Medicine and Director of the Clinical Electrophysiology Laboratory at Washington University School of Medicine; Edward W. Maibach, Ph.D., MPH, Professor and Director of the Public Health Communication Program at the School of Public Health and Health Services at George Washington University; Gerald V. Naccarelli, M.D., FACC, FAHA, the Bernard Trabin Chair in Cardiology, Professor of Medicine, Chief of Division of Cardiology, and Director of the Cardiovascular Center at Penn State University College of Medicine;  M. Jane Teta, Dr.PH, MPH, Principal Scientist and Practice Director of Health Sciences at Exponent, Inc.; and Joel I. Verter, Ph.D., Senior Investigator at Statistics Collaborative, Inc.  Peter O. Safir, Esq., a senior partner in Covington & Burling, served as counsel to the Panel.

The Panel's report in its entirety and background information regarding the Panel can be viewed at http://www.guidant.com/panel/.

   Contact: Robin Gilliland, 212-333-3810
            David Shapiro, 202-415-7337
            Naomi Decter, 202-393-7337


DATASOURCE: Independent Panel of Guidant Corporation



CONTACT:  Robin Gilliland, [phone], or David Shapiro,

[phone], or Naomi Decter, [phone], all for The Independent

Panel of Guidant Corporation 



Web site: http://www.guidant.com/panel 

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