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St. Jude Medical (STJ) Wins FDA Approval for New Remote Patient Monitoring System


1/22/2013 8:35:59 AM

Jan 21, 2013 (Datamonitor via COMTEX) -- St. Jude Medical, Inc., a medical device company, has received FDA approval for the next-generation Merlin.net Patient Care Network, or PCN, an internet-based remote care system for patients with implanted medical devices.

According to the company, the newest version of Merlin.net PCN provides clinicians with additional insight into changes in their patients' heart failure status through advanced impedance and lead monitoring capabilities, improving the management of patients at risk of sudden cardiac death or ventricular and atrial arrhythmias.

To assist physicians in diagnosing and managing patients with heart failure, the new version of Merlin.net PCN enables the remote transmission of patient data measured from CorVue Thoracic Impedance Monitoring, a diagnostic feature that tracks and reports changes in impedance that may reflect changes in heart failure status, monitored by St. Jude Medical implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The algorithm assesses impedance changes in multiple vectors of the heart throughout the day and provides the flexibility to customize diagnostic reports for each patient, the company said.

The latest version of Merlin.net PCN also features the LeadAssurance Alert, which builds upon existing monitoring capabilities by bundling new and existing notifications into one comprehensive alerting suite. Data from the LeadAssurance Alert offers nightly remote alert checks on high-voltage devices to ensure that lead performance is continually monitored and all diagnostics are reported to clinicians.

Merlin.net PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote device transmissions sent from a patient's home. Remote transmissions are sent via Merlin@home Transmitter, a system that allows patient data from an implanted cardiac device to be wirelessly downloaded and securely transmitted for clinician review.

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 personal health record, the company added.

"Merlin.net PCN's ability to monitor when there is a significant impedance change is an important advancement to remote monitoring technologies," said Dr Richard Waters of the Stockton Cardiology Medical Group in Stockton, Calif. "Clinicians using this technology will be able to detect heart failure symptoms earlier than ever before, optimizing care for patients who are at risk of worsening heart failure."

"The next-generation Merlin.net PCN was designed to advance disease management of cardiac conditions," said Eric Fain, president of the St. Jude Medical Implantable Electronic Systems Division (IESD). "In addition to advancing monitoring features, we have added broadband capabilities to increase patient access to home monitoring technology. As a company, we continue to focus on developing innovative remote monitoring technologies that enable earlier interventions for clinicians and accessible solutions for patients."



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