Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - January 22, 2008

St. Jude Medical Announces FDA Approval of Next Generation Internet-Based Data Management System for Implantable Cardiac Devices

Merlin .net Patient Care Network provides physicians with improved access to important patient device data

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of software and firmware updates to the Merlin™.net Patient Care Network (PCN). The new Merlin.net PCN 2.5 will expand availability of the system nationwide and provide physicians with improved options for remotely monitoring their patients with the most commonly-used St. Jude Medical implantable cardiac devices.

The upgraded system includes enhancements to the Housecall Plus™ transmitter which patients use to convey data from their devices over phone lines to the central Merlin.net PCN data repository. The new modifications offer improved ease of use for patients and physicians, a simple, one-step procedure for data transmission, expansion of services to include the entire U.S., and the ability to accommodate patients with devices who travel out of the U.S. by allowing them to transmit data from overseas.

The U.S. Veterans Health Administration (VA) has been using Merlin.net PCN since August 2007 (through its National ICD Surveillance Program). Currently, 20 VA Medical Centers have enrolled to provide remote monitoring service to veterans with St. Jude Medical defibrillators. Several special enhancements have been made in Merlin.net PCN to facilitate patient registration, transfer important device data to the VA National ICD Surveillance Program Web site, and electronically paste text-rich reports into the VA Computerized Patient Records System.

In addition, St. Jude Medical is the first and only cardiac rhythm management company to satisfy the requirements established by the IHE (Integrating the Healthcare Enterprise), which promotes the adoption of standards for sharing healthcare information seamlessly across clinical settings. Compliance with IHE standards supports the compatibility of Merlin.net PCN with electronic health record (EHR) systems. By designing in an open architecture, St. Jude Medical allows clinics and physicians to utilize Merlin.net with their choice of EHR system. Merlin.net PCN already has successfully integrated into major EHR systems, including GEMMS, Lumedx and NextGen (through eMedApps), and is expanding its integration with other systems.

“The integration between GEMMS and Merlin.net PCN represents two market leaders moving beyond just interfacing data. These two, strong integrated products give users – in this case hospitals and clinics – a seamless clinical workflow.” says Rodger P. Pinto, Ph.D., chief executive officer of GEMMS.

“Remote management of patients with implanted devices is critical to optimizing the value of these therapies,” said Steve Compton, M.D., chief of electrophysiology at Alaska Heart Institute. “The ability to merge information captured by the device into the patient’s electronic health record would ensure that we have a complete patient history from which to make clinical decisions. This can improve the quality of care and efficiency of patient management, especially for patients who are seen at more than one facility.”

Merlin.net PCN is an Internet-based central repository for patient device data that gives physicians immediate access to detailed information about the performance of the patient’s device, allowing them to assess the patient and determine the level of care needed. Patients with implantable cardiac devices use the Housecall Plus transmitter to send data from their devices directly to Merlin.net PCN from the comfort of their own homes. The system gives patients the freedom to send data, and physicians the ability to review it (during or outside of regular office hours), which may contribute to better early detection and care for patients with abnormal heart rhythms.

Merlin.net PCN provides storage for important data that is captured in a patient’s implantable cardiac device – from the implant procedure, in-office follow-up visits and remote follow-up transmissions. Transmitted data includes reports of any episodes of irregular heart rhythms as well as a real time electrogram (EGM) which shows the patient’s heartbeat at the time of transmission. Data transmitted to the central repository is available to physicians via a secure log-in, and can also be integrated into existing patient electronic health records (EHRs) to ensure a comprehensive patient history is generated and accessible.

“The enhancements to our Merlin.net PCN system will enable better efficiency for both physicians and patients,”said Eric S. Fain, president of the St. Jude Medical Cardiac Rhythm Management Division. “Seamless integration of patient data into electronic medical records is key to delivering and improving quality of care. We have developed Merlin.net PCN to be compatible with existing EHR systems, so physicians can use it with the clinic- and hospital-based systems they already have in use.”

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. Merlin.net PCN not only stores this information for physician access, but also allows data to be sent directly to a clinic's or hospital's EHR system so the data is included in the patient’s comprehensive personal health record. With immediate access to patient information through the secure Merlin.net PCN website, physicians can monitor and assess patient device data and determine the level of care needed remotely.

Merlin.net PCN supports all currently marketed Atlas® and Epic® family implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) device families in the U.S. The Merlin.net system adheres to the 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

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.

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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). 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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