FDA approves St. Jude Medical’s Merlin.net Patient Care Network

Published on January 17, 2013 at 1:31 AM · No Comments

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the next-generation Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices. 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 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.

"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 latest version of Merlin.net PCN also features the LeadAssurance™ Alert, which builds upon existing lead 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.

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