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Guidant Independent Panel Recruited, Begins Deliberations.


INDIANAPOLIS -- Dr. Robert J. Myerburg, Professor of Medicine and Physiology at the University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University.

The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U
 and recently appointed chair of Guidant's (NYSE NYSE

See: New York Stock Exchange
:GDT) Independent Panel, has notified the company that he has completed recruitment of panel members.

"I am extremely pleased to have the opportunity to work with this distinguished panel of experts," said Dr. Myerburg. "The issues we will be analyzing are complex, but extraordinarily important for patients, physicians and industry. The enthusiasm I sensed from each of the panelists makes me optimistic that we will achieve contributions that are relevant to all of the stakeholders."

"We are delighted that such a distinguished panel will advise us on some of the most critical issues facing our industry today," said Ronald W. Dollens, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Guidant Corporation. "We look forward 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 Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, . 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 MACC Master of Accountancy
MACC Mexican American Cultural Center (Texas)
MACC Moberly Area Community College (Missouri)
MACC Mine Action Coordination Center
, FAHA FAHA Florida Air Hockey Association
FAHA Fellow of the American Heart Association
FAHA Florida Association of Homes for the Aging
FAHA Fellow of the Australian Academy of the Humanities
FAHA Finnish American Heritage Association
, 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 The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. .

--John P. DiMarco, M.D., Ph.D., FACC FACC Fellow, American College of Cardiology , 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 Arizona State University, at Tempe; coeducational; opened 1886 as a normal school, became 1925 Tempe State Teachers College, renamed 1945 Arizona State College at Tempe. Its present name was adopted in 1958. . He was formerly Director of the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.  (CDRH CDRH Center for Devices and Radiological Health (US FDA) ). 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 Stanford University School of Medicine is affiliated with Stanford University and is located at Stanford University Medical Center in Stanford, California, adjacent to Palo Alto and Menlo Park. . 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 Washington University School of Medicine, located in St. Louis, Missouri, is one of the most competitive and highly regarded medical schools and biomedical research institutes in the United States. . 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 George Washington University, at Washington, D.C.; coeducational; chartered 1821 as Columbian College (one of the first nonsectarian colleges), opened 1822, became a university in 1873, renamed 1904. . 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 Burling may refer to:
  • Carroll Burling
  • Daniel Burling
  • Robbins Burling

This page or section lists people with the surname Burling. If an internal link for a specific person referred you to this page, you may wish to add the given name(s) to that
, will serve as counsel to the Panel. Mr. Safir is recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country.

The Panel will hold its first meeting August 30-31. The Panel's deliberations in full session and subcommittees will continue through early winter. The goal is to present its complete report within six months.

The Panel will first review and analyze, and then provide specific recommendations to Guidant Corporation, regarding four core issues defined 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 both internal information from Guidant Corporation and other sources, the Independent Panel will report on ways that Guidant Corporation can further enhance capabilities in understanding, detecting and disseminating important information. In addition, the Panel will make public its non-proprietary observations and recommendations regarding these issues that may be useful to others in the device industry, regulatory bodies and clinical community.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 12,000 employees, 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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 29, 2005
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