St. Jude Medical's
St. Jude's Wi-Fi* Pacemaker Wins Approval
August 12, 2009
FDA in late July approved St. Jude Medical's wireless pacemaker and resynchronizer, the first wi-fi devices to hit the market, Amy Meyer, a St. Jude spokeswoman, told DOTmed News this week.
Meyer says a CRT-P resynchronizes the beating of the heart's lower chambers, which often beat out of sync in heart failure patients. She says the wi-fi device lets doctors view heart patients' implanted devices remotely. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the clinic or via remote monitoring from the patient's home, the company says.
Patient device follow-up can be scheduled to take place automatically in a hands free manner, with no patient interaction required. Information from the device is then captured by the Merlin@home(r) 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.
Simplified Patient Management
The devices have several features that simplify patient management, the company says. These features include AT/AF Alerts, AutoCapture(r) Pacing System technology that measures the heart's reaction to pacing beat-by-beat, and the VIP(r) algorithm that enables the heart's intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.
The AT/AF Alert feature helps to better assist physicians in accurately diagnosing and managing patients with fast rates in the heart's upper
chambers, called the atria.
This feature is designed to notify physicians when a rapid atrial rate, atrial tachycardia or atrial fibrillation (AT/AF), exceeds a programmed value or occurs over an extended period of time. The devices also can be programmed to notify the patient of AT/AF episodes, as well as device- and lead-related issues, through a two-tone audible alert. In addition, the patient's clinic can be informed through the home monitoring system.
"The automatic alerts provided by the RF telemetry built in to the Accent RF and Anthem RF devices enhance my ability to manage patients' heart conditions and disease progression, something that is particularly important for patients with heart failure or other co-morbidities," says Steven Greenberg, M.D., coordinator of the Arrhythmia and Pacemaker Center at St. Francis Hospital in Roslyn, New York. Dr. Greenberg tested the wi-fi devices, leading to their approval.
"Rather than checking the device a few times a year, the daily alerts allow me to know about important changes in my patient's condition or device functions so I can act more quickly in addressing any issues," Dr. Greenberg says.
The St. Jude Medical Ventricular Intrinsic Preference (VIP) algorithm allows the device to monitor the heart beat-by-beat and provide pacing only when necessary. Allowing the patient's natural heart rhythm to work on its own when possible has been shown to benefit overall heart health.
With the combination of advanced features and efficiencies provided by the company's consolidated Unity device platform, the Accent RF pacemaker and Anthem RF CRT-P offer significantly improved battery longevity and a seven-year warranty.
Alert notification delivery times can be customized to fit in with physician determined clinic hours, including any after-hours processes the clinic might provide. Version 4.0 of Merlin.net PCN provides an additional feature called DirectTrend(tm) Viewer, which graphically displays patient trends and disease progression. This allows physicians to more effectively manage patients through interactive views of patient data over time, the company says.
Source: St. Jude Medical
*Ed note: A clinical engineer has taken issue with our loose use of the term "WiFi." See his comments below and please add your own view on this topic.
You need to clarify your terms, the use of the term Wi-Fi is incorrect.
Pacemakers and ICDs use RF (radiofrequency) telemetry communications in
a frequency band that is regulated by the FDA and FCC. Previously, the programmer telemetry head had to be directly over the device. With the new RF remote telemetry features, the communication can be made within a short distance (i.e same or next room). Previously, it was only available in ICDs. The only thing new about St. Jude's approval is that it is the first pacemaker in the industry to have the RF remote telemetry technology. RF remote telemetry and remote monitoring is not new to this industry. Remote monitoring has been around a number of years in both pacemakers and ICDs. The RF remote telemetry has only been around in ICDs for only a few years.
The term wi-fi, on the other hand, refers to the 803.11x (A, B, G, or N) that is used for wireless communications between computers, networks, and other auxillary hardware.
--Richard Clark, Clinical Engineer