WASHINGTON, September 28, 2006 -- The Heart Rhythm Society today issued final recommendations to provide heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs). The recommendations also offer specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance issues and advisories for implantable cardiac devices. In addition, the final recommendations report also addresses international principles related to device performance.

The report will be published in the October issue of Heart Rhythm.

"This report offers the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs," said Dwight Reynolds, MD, FHRS President of the Heart Rhythm Society. "These changes will help patients continue to have confidence and trust in these lifesaving treatments."

The overarching objectives of the recommendations include the following:

• Greater transparency in the post-market surveillance, analysis and reporting of information;
• The establishment of new systems to identify malfunctioning devices more quickly;
• Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA and physicians are encouraged to work together to prevent adverse events due to device malfunctions; and
• The global scope of device performance issues; cooperation among industry, physicians, government authorities and national health care systems are necessary to reduce the risk of injuries and deaths due to device malfunctions.

"The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients and other stakeholders to ensure that these recommendations will guide key policy de
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Contact: Rachael Lille Moore
rmoore@HRSonline.org
202-464-3476
GYMR
28-Sep-2006