News | July 15, 2008

St. Jude Gets FDA Approval For Wireless Transmitter to Monitor Implanted Cardiac Devices

July 16, 2008 - St. Jude Medical Inc. this week said it received FDA approval of the [email protected] 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).

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, the company said patients are now able to initiate and perform many of these follow-ups in their own homes.

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, the company said. Patients also may initiate data transmissions as instructed by their physicians.

The [email protected] 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 [email protected] 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.

The [email protected] 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.

The [email protected] transmitter will be available in the U.S. early this fall and internationally in the fourth quarter.

For more information: www.sjm.com

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