Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology FDA Monitoring

 News Release - July 15, 2008

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

Merlin@home transmitter automatically monitors patients with implantable cardiac devices and alerts physicians if patients or devices require attention

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today 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 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. 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 in the U.S. early this fall and internationally in the fourth quarter.

About Merlin.Net Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record vast amounts of information about device performance and patient heart rhythms that is vital to patient care. PCN not only stores this information for physicians to review, but also allows data to be sent directly to a clinic's or a hospital's electronic health records (EHR) system so the data is included in the patient’s comprehensive personal health record. With immediate access to patient information through the secure PCN website, physicians can remotely monitor and assess patient device data and determine the level of care needed. Alert notification delivery times can be customized by the physician.

Other PCN features include DirectCall™ Message, which uses an interactive voice recognition (IVR) system to call patients to remind them of upcoming scheduled follow-ups, inform them if they have missed a follow-up, confirm that their transmitted data has been reviewed or ask them to call their physician’s office for more information. 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 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).

About St. Jude Medical and Connectivity

St. Jude Medical is the only cardiac rhythm management company able to transfer information directly from the remote care system to a patient’s electronic health record using the requirements established by the IHE (Integrating the Healthcare Enterprise), which promotes standards for securely sharing healthcare information across clinical settings. Meeting these standards helps make the transfer of patient data from PCN to the clinic’s electronic health record (EHR) system seamless and secure.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Source: St. Jude Medical

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