The draft offers specific recommendations to industry, FDA, Congress and physicians for the surveillance, analysis and performance reporting of cardiac devices. The recommendations provide patients with clearer, timelier and more consistent information about the recalls and advisories of cardiac devices. This is the first time comprehensive guidelines have been developed to help physicians make critical decisions about responding to advisories.
What: A telephone briefing to announce the Heart Rhythm Societys draft policy recommendations for pacemaker and implantable cardioverter defibrillator (ICD) performance.
Who: Telebriefing participants include:
When: Wednesday, April 26, 2006 10:00 AM ET
RSVP: Contact Rebecca Leaf at 202-745-5051, firstname.lastname@example.org / to receive the confirmation code.
This telebriefing is for credentialed media only.
Call-in telephone number: (866) 550-6338 (a confirmation code is needed to enter the call) Call-in replay information: (888) 203-1112 (passcode 6630214) from 2:00 p.m. ET on 4/26/06 until 11:59 p.m. ET on 4/30/06
History: In September, 2005, the Heart Rhythm Society convened a policy conference to discuss issues related to the performance of pacemakers and ICDs. As a result of that meeting, the Society assembled a 15-member task force of leading cardiac care providers and experts who were charged with the development of draft guideline recommendations. Additionally, the Task Force worked with regulators from the Food and D
Contact: Rebecca Leaf