FDA Approval For Accent RF, Anthem RF CRT- Pacemakers Using Wireless Technology

The U.S. Food and Drug Administration has approved St Jude's Accent RF pacemaker and Anthem RF cardiac resynchronization therapy pacemaker or RF CRT-P that simplyfy patient management. The company also received FDA and European CE Mark approval for version 4.0 of Merlin.net Patient Care Network or PCN, which supports the Accent RF and Anthem RF devices.

The Accent and Anthem product mix features RF telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician or a home monitor. The company said wireless communication can be performed in the clinic or via remote monitoring from the patient's home.

St. Jude further explained that the patient device follow-up needs no patient interaction and can be scheduled to take place automatically, in a hands free manner. The data is then captured by the transmitter, and becomes available for viewing by the clinician via Merlin.net PCN. In addition to fast access to device data, Merlin.net PCN also allows physicians to compile a more complete patient record, by easily transferring cardiac device data into electronic health records.