St Jude Medical wireless transmitter for implanted cardiac devices gains FDA approval

2 August 2008

St Jude Medical, Inc. (NYSE:STJ) has received US FDA approval for its wireless system for transmitting data from implanted cardiac devices. The Merlin@home transmitter enables remote monitoring of patients' implanted cardiac devices by medical staff.

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, 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 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 Dr Eric Fain, 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. 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 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."

The Merlin@home transmitter will be available both in the US and internationally later this year.

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