September 28, 2005

On Friday, September 16, 2005, the Heart Rhythm Society, convened an unprecedented one-day Policy Conference on Pacemaker and ICD Performance to discuss the current state of ICD and pacemaker technology, performance, and post market surveillance. Topics on the agenda also included the role of external databases in post market surveillance, risk/benefit communication, and issues related to manufacturer/FDA/patient/physician communication.

The conference served as a first step to an improved device surveillance system. The Policy Conference included an acknowledgement that changes and improvements in the post market surveillance system are needed to improve patient care. The Heart Rhythm Society is committed to ensuring appropriate and timely performance data from ICDs and pacemakers are reported to manufacturers, the Food and Drug Administration, heart rhythm specialists, and most importantly, to patients.

The Conference, co-sponsored by the United States Food and Drug Administration (FDA), was chaired by Mark Carlson, MD. Over forty speakers and panelists presented information and engaged in discussion with over 330 registered attendees. Representatives from the Heart Rhythm Society leadership, membership, officials from the FDA, Centers for Medicare and Medicaid Services, Congress, patient advocacy groups, the medical device industry, and representatives from the legal and financial sector were active participants in the day's events.

The Policy Conference was widely cited in the media including- the New York Times , Wall Street Journal , Washington Post , Minneapolis Star Tribune , St. Paul Pioneer Press , AP, National Public Radio and Reuters among others.

A summary proceedings document will be available on the Heart Rhythm Society website in mid-October. Members will receive an email alert when it becomes available. If you were not able to attend this historic meeting, your thoughts and opinions are important to the Society. The Society is holding a Public Comment period on the Policy Conference. Discussion points relating to each specific topic are provided. The Society will use your comments as future policy and clinical recommendations are developed. Please submit your comments by midnight on Monday, October 10, 2005.

As policy recommendations focusing on improving the post-market surveillance system for pacemakers and ICDs are developed, the Heart Rhythm Society will communicate them to the membership and seek wider input through the Public Comment process. I look forward to reporting future developments as we work with the various stakeholders such as the FDA, industry, and patients towards developing public policy recommendations improving ICD and pacemaker surveillance, and ultimately patient care.

Sincerely,

Anne B. Curtis, MD
President
Heart Rhythm Society