Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology Regulatory

 News Release - April 24, 2009

St. Jude Medical Announces CE Mark Approval of Remote Care System for Implantable Cardiac Devices

Cutting-edge Web-based system, Patient Care Network (PCN), combines tools that can help physicians monitor patients and improve clinic efficiency

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its™ Patient Care Network (PCN). PCN is a secure, Internet-based remote care system that gathers and stores data from the implant procedure, a clinic follow-up visit or from remote follow-up transmissions of patients with implanted cardiac devices. The system includes a range of features designed to improve clinic efficiency and to enhance patient care by giving physicians better and more immediate access to information. With its open architecture and standards-based interface, PCN can be fully integrated with all standard electronic health record (EHR) systems in hospital or clinic settings.

Until recently, the only way for physicians to check on their patients’ devices was for a patient to come to their clinic in person. Now, information from a patient’s implanted device can be transmitted remotely from the comfort of a patient’s home. St. Jude Medical patients with compatible devices can use the Merlin@home™ transmitter to send data directly from their devices to PCN. Physicians can even use PCN to schedule the remote follow-up to take place at night, while the patient is sleeping.

Remote monitoring provides daily checks on the patient’s device. If the check reveals an event that may require timely intervention, an alert will be posted on PCN and transmitted to the physician via email, fax or SMS text. PCN offers a set of flexible tools that allow the physician to choose when, where and how alerts are communicated during off-clinic hours, including the transfer of alerts to after hours support services. Alert-triggering events are not restricted to device performance, but also include clinical episodes such as atrial tachycardia (AT), atrial fibrillation (AF), and ST segment change notifications for remote disease management.

A key exclusive feature of PCN is DirectCall™ Message, an automated calling system that the clinic staff can use to call patients with up to four pre-recorded messages in any of approximately 20 languages. The system can be used to remind patients of an up-coming scheduled follow-up, notify them that they have missed a scheduled follow-up, inform them that their remote transmission has been received and everything looks normal, or ask them to call the clinic to discuss the results of the follow-up. These are all routine calls that are regularly made by clinic staff. With this new technology, clinics can quickly and efficiently provide information to patients regarding their device status for enhanced assurance.

St. Jude Medical is a leader in the integration of remote care technology with hospital and clinic EHR systems. Anticipating the rapid adoption of EHRs for storing patient data in the healthcare industry, PCN was built on an open architecture platform, which allows for the seamless transfer of data to major EHR suppliers’ systems. Other efficiency features include a unique online scheduling tool that allows clinics to create schedules that are automatically adjusted for clinic holidays, and data management options such as batch reviewing, printing and storing multiple patient files.

The system has been adopted widely into clinics and hospitals in the United States since it was released in 2008.

“The success of PCN in the United States has been built through a combination of tools that offer physicians more control over their patients’ device monitoring and features that help their clinics run more efficiently,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "We are delighted to now offer these benefits to our customers and to patients in Europe.” PCN will be launched in Europe this spring.

About Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record large volumes of data on device performance and patient heart rhythms vital to patient care. PCN is a secure information network that stores this information for a minimum of seven years, allows data to be viewed over the internet by select users, and sends data directly to a clinic's or a hospital's electronic health records (EHR) system as part of a patient’s comprehensive personal health record.

With rapid access to patient information through the secure PCN Web site, physicians can remotely monitor and assess patient device data to determine their required level of care. Alert notification delivery times can be customized to fit clinic hours, including potential after-hours notifications based on the clinics’ preferences. PCN supports the Current® RF implantable cardioverter defibrillators (ICDs) and Promote® RF Cardiac Resynchronization Therapy defibrillator (CRT-D) family of devices and all currently marketed Atlas® ICD and Epic® CRT-D device families. 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

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 approximately 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular 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 for the fiscal year ended January 3, 2009. 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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