St. Jude’s remote monitoring system gets FDA go-ahead

The FDA has approved St. Jude’s next-generation Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

The newest version of PCN informs clinicians about changes in their patients’ heart failure status through advanced impedance and lead monitoring capabilities. It 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 implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

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, according to St. Paul, Minn.-based St. Jude.

The latest version also features the LeadAssurance Alert. 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. 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 a transmitter system that allows patient data from an implanted cardiac device to be wirelessly downloaded and securely transmitted for clinician review. It also allows data to be sent directly to a clinic's or a hospital's EHR system so the data are included in the patient’s comprehensive personal health record.