FDA approves St. Jude pacemaker that can connect data to EHRs

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The FDA has approved St. Jude Medical's Accent RF pacemaker and Anthem RF CRT-P (cardiac resynchronization therapy pacemaker). The company also reported FDA and European CE Mark approval of version 4.0 of the Merlin.net Patient Care Network (PCN), which supports the Accent RF and Anthem RF devices.

The St. Paul, Minn.-based company said its Accent and Anthem product family features radiofrequency (RF) telemetry that enables wireless communication between the implanted device and the programmer used by the clinician or a home monitor.

Patient device follow-up can be scheduled to take place automatically, St. Jude said. Data from the device is then captured by the Merlin@home transmitter, and becomes available for viewing by the clinician via Merlin.net PCN. In addition to access to device data, Merlin.net PCN allows physicians to compile a complete patient record, by transferring cardiac device data into EHRs.

The Accent RF pacemaker and Anthem RF CRT-P's features include: Atrial Tachycardia/Atrial Fibrillation Alerts; AutoCapture pacing system technology that measures the heart's reaction to pacing beat-by-beat; and the Ventricular Intrinsic Preference algorithm that allows the device to monitor the heart beat-by-beat and provide pacing only when necessary.