News | March 17, 2009

St. Jude Medical Gets FDA Clearance of New Features for Remote Monitoring for Implantable Cardiac Devices

March 16, 2009 - St. Jude Medical Inc. today announced FDA clearance of the newest version of the Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

This remote care system gathers and stores data from the implant procedure, in clinic follow-up visits or from both patient-initiated and automatic remote follow-up and monitoring transmissions. The updated Merlin.net PCN Version 3.1 expands on features designed to improve clinic efficiency and enhance patient care by giving physicians better and more immediate access to information to help them manage their patients’ devices. With its open architecture and standards-based interface, Merlin.net PCN is also fully integratable with all standard electronic health record (EHR) systems, the company said.

The latest version of Merlin.net PCN adds new options to its DirectAlerts Notification feature, which can be used to alert a physician – including an on-call physician outside normal business hours – to changes in the device or the patient’s disease state. The DirectAlerts Notification feature allows the physician to monitor patients for changes in certain diagnostic criteria between scheduled follow-ups, which would trigger the device to automatically store the data, send it to Merlin.net PCN and notify the physician that the data is available to review. The range of possible triggers now includes episodes of atrial fibrillation (AF).

The DirectCall Message feature provides prerecorded messages that clinics can program to call patients to remind them of an up-coming scheduled follow-up transmissions, notify them if they have missed a scheduled follow-up transmission, inform them that their remote transmission has been received and all looks normal, or ask them to call the clinic to discuss the results of the follow-up. Reducing the need for clinic staff to make and receive routine calls can help free up staff time while supporting increased patient compliance with their follow-up schedule. The new version of the patient care network also provides a Spanish language option so that clinics can serve a wider population of patients.

The Merlin.net PCN has enhanced online scheduling tools. The scheduling tools now offer both a smart calendar feature, which allows clinics to create schedules that automatically adjust for clinic holidays, and a manual scheduling function that is fully customizable for greater flexibility.

For more information: www.sjm.com

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