FDA Clears St. Jude’s New Version of Remote Patient Monitoring System
St. Jude Medical’s new version of its Merlin.net Patient Care Network (PCN) offers a secure, Internet-based remote care system is for patients with implanted implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices and pacemakers. 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 accurately 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 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 latest version of Merlin.net PCN also features the LeadAssurance Alert, which bundles 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.
The U.S. Food and Drug Administration (FDA) has cleared the system in January 2013.
For more information: sjm.com