29.08.2005 15:03:00
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Guidant Independent Panel Recruited, Begins Deliberations
"I am extremely pleased to have the opportunity to work with thisdistinguished panel of experts," said Dr. Myerburg. "The issues wewill be analyzing are complex, but extraordinarily important forpatients, physicians and industry. The enthusiasm I sensed from eachof the panelists makes me optimistic that we will achievecontributions that are relevant to all of the stakeholders."
"We are delighted that such a distinguished panel will advise uson some of the most critical issues facing our industry today," saidRonald W. Dollens, president and CEO, Guidant Corporation. "We lookforward to their recommendations."
The roster of Independent Panel members includes the following:
-- George E. Apostolakis, Ph.D., is Professor of Nuclear Science and Engineering and Professor of Engineering Systems at Massachusetts Institute of Technology. Dr. Apostolakis has internationally recognized expertise in risk and reliability assessment of complex technological systems, as well as decision analysis and risk management.
-- George A. Beller, M.D., MACC, FAHA, is Professor of Cardiology at University of Virginia Health System. Dr. Beller is a renowned cardiologist, thought leader in the field and clinical researcher. He is a past President of the American College of Cardiology.
-- John P. DiMarco, M.D., Ph.D., FACC, FAHA, is Professor of Medicine at University of Virginia Health System. Dr. DiMarco is an internationally respected clinical cardiac electrophysiologist, recognized for his analysis of the benefits and risks of various treatments of cardiac arrhythmia.
-- David W. Feigal, M.D., MPH, is Research Professor of the Arizona Biodesign Center at Arizona State University. He was formerly Director of the FDA Center for Devices and Radiological Health (CDRH). Dr. Feigal is a recognized expert in issues of biodesign and medical product development.
-- Kenneth Goodman, Ph.D., is Associate Professor of Medicine and Philosophy and Director of the Bioethics Program in the University of Miami Ethics Program. Dr. Goodman is a widely recognized expert in ethics and integrity in scientific research, and medical ethics regarding patient care and decision-making.
-- Sharon A. Hunt, M.D., FACC, is Professor of Medicine at Stanford University School of Medicine. Dr. Hunt is a cardiologist, internationally recognized for her expertise in advanced heart failure. She recently served as Chair of the American College of Cardiology/American Heart Association task force on practice guidelines for heart failure.
-- Bruce D. Lindsay, M.D., FACC, is Associate Professor of Medicine and Director of the Clinical Electrophysiology Laboratory at Washington University School of Medicine. Dr. Lindsay is a leader in the detection and treatment of cardiac arrhythmias through the use of Implantable Cardioverter Defibrillators (ICDs).
-- Edward W. Maibach, Ph.D., MPH, is Professor and Director of the Public Health Communication Program at the School of Public Health and Health Services at George Washington University. Dr. Maibach is an expert on communication and social marketing issues relating to public health.
-- Gerald V. Naccarelli, M.D., FACC, FAHA, is 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. Dr. Naccarelli is a leading cardiologist, specializing in cardiac electrophysiology, who has been an investigator in multiple electrophysiology device and pharmaceutical trials.
-- M. Jane Teta, Dr.PH, MPH, is Principal Scientist and Practice Director of Health Sciences at Exponent, Inc. Dr. Teta is a recognized expert in chronic disease epidemiology, regulatory risk assessment, as well as risk communication to the media and public.
-- Joel I. Verter, Ph.D., is Senior Investigator at Statistics Collaborative, Inc. Dr. Verter has internationally recognized expertise in the statistical estimation and modeling of low-frequency adverse events and risk.
Peter O. Safir, Esq., a senior partner in Covington & Burling,will serve as counsel to the Panel. Mr. Safir is recognized in thepharmaceutical industry as one of the leading food and drug regulatorylawyers in the country.
The Panel will hold its first meeting August 30-31. The Panel'sdeliberations in full session and subcommittees will continue throughearly winter. The goal is to present its complete report within sixmonths.
The Panel will first review and analyze, and then provide specificrecommendations to Guidant Corporation, regarding four core issuesdefined in the formal charter of the Independent Panel:
-- Surveillance and interpretation of low-frequency trends among life-sustaining implantable devices that may affect patient safety and physician decisions for device management.
-- Reassessment of benefit and risk to patients in light of new information about marketed devices.
-- Device component failure analysis and estimation of its frequency.
-- Development of more transparent, understandable and clinically useful communication processes to physicians and patients, including triggers for communication, timing, and novel methods of transferring information.
In conformance with FDA and regulatory guidelines, and using bothinternal information from Guidant Corporation and other sources, theIndependent Panel will report on ways that Guidant Corporation canfurther enhance capabilities in understanding, detecting anddisseminating important information. In addition, the Panel will makepublic its non-proprietary observations and recommendations regardingthese issues that may be useful to others in the device industry,regulatory bodies and clinical community.
Guidant Corporation pioneers lifesaving technology, giving anopportunity for better life today to millions of cardiac and vascularpatients worldwide. The company, driven by a strong entrepreneurialculture of more than 12,000 employees, develops, manufactures andmarkets a broad array of products and services that enable lessinvasive care for some of life's most threatening medical conditions.For more information, visit www.guidant.com.
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