St. Jude Medical Announces FDA Approval Of Next-Generation Remote Monitoring And Data Management System For Implantable Cardiac Devices

Main Category: Cardiovascular / Cardiology
Article Date: 14 May 2008 - 3:00 PST

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St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) approval of the next-generation Merlin.Net Patient Care Network (PCN), an Internet-based central repository for patient device data gathered at the time of implant procedures, at in-clinic follow-up visits or from patient-initiated remote follow-up appointments. The next-generation Merlin.net PCN Version 3.0 includes an automated interactive voice response feature, DirectCall™ Message, which clinics can use to make routine telephone calls to patients.

The DirectCall Message automated system can call patients to remind them of upcoming remote follow-up appointments, or to notify them if they miss a remote follow-up appointment. DirectCall Message also can be used to ask patients to call the clinic, or to inform patients that their remote transmissions have been reviewed by the clinic and the results look normal. DirectCall Message does not replace office visits or reduce contact with physicians. However, it is expected to reduce the number of routine calls usually made by clinic staff, while making sure that patients receive important reminders and notifications. It is intended to reduce clinics' administrative burdens and increase efficiencies.

"The next-generation Merlin.net PCN helps physicians enhance patient care while improving their administrative efficiency," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Seamless, secure data transfer, along with DirectCall Message, free up time that can now be spent dealing with more critical patient needs."

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 Merlin.net PCN to the clinic's electronic health record (EHR) system seamless and secure.

Merlin.net PCN's integration with hospitals' and clinics' EHR systems has been enhanced through an exclusive partnership with Healthvision, whose healthcare-specific software and services allow clinics and hospitals to integrate data regardless of the type of data or the format in which it exists. This partnership allows St. Jude Medical to work with more clinics and hospitals, helping them to improve business workflow and operational efficiencies, and to better manage the health of their patients. With both IHE and Healthvision as tools to achieve interoperability for its customers, St. Jude Medical offers direct connections to an expanding pipeline of major EHR systems, including GEMMS, eMedApps, Lumedx and Medical Informatics Engineering, and is expanding its integration with other systems. Its commitment to patient data management reflects the growing importance of EHRs in everyday clinic administration.

"Electronic Health Records are becoming a necessary and useful part of our clinical lives," said Scott Hessen, M.D., chief, Clinical Cardiac Electrophysiology, Cardiology Consultants of Philadelphia. "The interoperability offered by Merlin.net PCN will help us integrate patient data more easily, giving us complete health profiles of our patients and a basis for better treatment decisions that can improve patient outcomes and reduce costs."

When dealing with electronic patient information, privacy is a significant concern for physicians and patients. The entire Merlin.net PCN system, from user access to data storage, meets the standards of reliability, privacy and security established by regulatory requirements and by the International Quality Certification Standards. All network communications that occur on Merlin.net PCN are encrypted with the highest level of protection using industry standard cryptography. To ensure that no unauthorized viewers can access patient data while the Web site is in use, all access to Merlin.net PCN is password protected and any suspicious activity is monitored.

"Because security and privacy are so important, the Merlin.Net PCN system security is subject to regular assessments by independent, third-party computer security specialists," said Fain. "We work continually to keep security and privacy protection standards updated. We want our customers, and their patients, to be confident in our commitment to ensure Merlin.Net PCN remains effective, efficient, protected and secure."

Merlin.net PCN 3.0 will be featured at Heart Rhythm 2008, which takes place May 14-17 at the Moscone Convention Center in San Francisco. The meeting is the most comprehensive educational event on heart rhythm disorders, offering 250 educational opportunities in multiple formats. The world's most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators. http://www.sjm.com

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 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 Merlin.net PCN website, physicians can monitor and assess patient device data and determine the level of care needed remotely. The Merlin.net PCN 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) and will be the platform for future St. Jude Medical device remote monitoring.

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 12,000 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 http://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 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.

St. Jude Medical