FDA approves new version of St. Jude Medical internet-based remote care system for implanted medical devices

Mar 16 2009

St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) approval 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 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), a serious condition characterized by rapid, ineffective contractions of the upper chambers of the heart that, if unmanaged, can increase the risk of stroke.

"Developing a variety of methods to tackle the threat of AF through innovative technology is a major commitment that we have made at St. Jude Medical," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Adding AF episodes to our alert options allows physicians to access information quickly when these episodes occur and take more control over the management of their patients' condition."

The DirectCall Message feature provides pre-recorded 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 United States Census Bureau estimates that more than 34 million people, or 12 percent of the U.S. population, speak Spanish as their primary language," said Fain. "St. Jude Medical is pleased to serve Spanish-speaking patients by providing them with information about their medical care in their preferred language."

The Merlin.net PCN has enhanced unique 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.

About Merlin.Net Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a 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 remotely monitor and assess patient device data and determine the level of care needed. Alert notification delivery times can be customized to fit in with physician determined clinic hours, including any after-hours processes the clinic might provide.

Merlin.net PCN supports the Current RF and Promote RF family of devices and 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 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).