June 22, 2005
FOR IMMEDIATE RELEASE

Contact:
Charlie Jones
202-464-3400

Brian Ruberry
240-506-6323

WASHINGTON, June 21, 2005 —The Heart Rhythm Society has formed a task force to begin drafting recommendations for uniform notification standards to inform physicians and patients about safety alerts and recalls of implantable cardioverter defibrillators (ICDs). The Task Force on Device Performance will finalize the standards—including recommendations for physicians on when to replace an ICD—at a public policy conference in Washington in the fall. The meeting will include representation from the Food and Drug Administration (FDA), clinicians, media, manufacturers, and cardiac and patient organizations.

“These new guidelines will focus on what is always our first priority: patient safety,” says Anne B. Curtis, MD, president of the Heart Rhythm Society. “We’re taking the lead in developing these guidelines, just as we’ve been the industry leader in establishing universal standards of care for heart rhythm disorders for 25 years.”

While the guidelines are being developed, Dr. Curtis says the Heart Rhythm Society concurs with the FDA in recommending that patients affected by recalls seek the medical advice of their heart rhythm specialists.

“Patients need to discuss the variety of treatment options available with the heart rhythm specialist overseeing their care,” she says. “Each patient is unique and the decision regarding ICD treatment based on recall information from the manufacturer and the FDA will depend on the patient’s specific medical condition.

“Despite recent device recalls, the benefits of sudden cardiac arrest prevention conveyed by the ICD, far outweigh the risk of device failure,” she concludes.

# # #