HIPAA News

St. Jude Medical Announces FDA Approval of Wireless Transmitter to Monitor Patients' Implanted Cardiac Devices

(July 16, 2008)-- St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of the Merlin@home transmitter, an RF wireless technology that remotely monitors patients’ implanted cardiac devices. The transmitter supports the St. Jude Medical Current® RF and Promote® RF family of devices and works in conjunction with the St. Jude Medical data management system, Merlin™.net Patient Care Network (PCN), to provide complete remote care service for patients and their physicians.

Until recently, patients with implanted cardiac devices were typically required to visit doctors’ offices several times per year to have their device performance checked. With the advent of transmitters capable of downloading and transmitting device data over telephone lines, patients are now able to initiate and perform many of these follow-ups in their own homes.

The Merlin@home transmitter’s wireless technology gives patients the additional comfort of having devices automatically checked. Since the transmitter initiates the scheduled follow-up and uses RF wireless telemetry to download data from the device, the entire follow-up procedure is conducted without any direct patient involvement. The only requirement is that each patient remains within range of the transmitter while it reads his or her device. Patients also may initiate data transmissions as instructed by their physicians.

The Merlin@home transmitter is transportable and can be set-up wherever a standard phone line is available, typically by the bedside for data transmission while the patient sleeps. Data downloaded by the Merlin@home transmitter is sent to Merlin.net PCN, a secure, Internet-based data management system, where it is stored for review by the patient’s physician.

“We have simplified remote follow-ups to the extent that they are now something that can be performed seamlessly without interrupting the patient’s day. Patients simply set-up the Merlin@home transmitter; after that, the system handles all aspects of patient follow up, including daily monitoring,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The simplicity of the system reduces the chance of patients missing follow-up transmissions.”

The Merlin@home transmitter also monitors cardiac devices outside of regularly scheduled follow-ups. The system can perform daily checks to monitor for alerts about device performance or about patient heart rhythms that may have been detected by the implanted device. Merlin.net PCN can be programmed to alert a physician directly – including an on-call physician outside normal business hours – in the event that the monitored data reveals an episode the physician needs to know about as soon as possible.

“By directly alerting physicians, the Merlin@home transmitter and Merlin.net PCN can help reduce risks associated with cardiac episodes that physicians would want to know about right away,” said Fain. “Without this notification, these events might go undetected for significant amounts of time. Direct notification is one more way to give physicians more control over their patient’s critical health care.”

Merlin.net PCN supports all currently marketed Atlas® and Epic® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the U.S, as well as Current® RF and Promote® RF devices. The Merlin.net PCN system adheres to patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

For more information, please visit www.sjm.com.

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