FDA Approves New Version Of St.Jude’s Remote Patient Monitoring System

In short

St. Jude Medical, Inc. has gained U.S. FDA approval for its 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.

Background

St.Jude says its new version of Merlin.net PCN assists physicians in accurately diagnosing and managing patients with heart failure, through remote transmission of patient data measured from CorVue® Thoracic Impedance Monitoring. This diagnostic feature tracks in real time and reports changes in impedance that may reflect changes in heart failure status.

The new system also features the LeadAssurance™ Alert, which 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 implanted cardiac devices during the implantation procedure, in-clinic follow-up visits and from remote device transmissions sent from a patient’s home via a broadband internet connection.

The remote monitoring capabilities facilitated by the Merlin@home transmitter permit automated follow-up appointments and daily device checks to occur wirelessly, with limited patient action required.

We’ve seen research showing that remote monitoring ticks several boxes: It can reduce visits to the physician’s office, while improving patient care by allowing physicians to become aware of changes with the patient’s condition or device more quickly. Additionally the collected data allows physicians to compile a more complete patient record by easily transferring cardiac device data into electronic health record (EHR) systems.

Physician comments

“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.”

Company comments

“The next-generation Merlin.net PCN was designed to advance disease management of cardiac conditions,” said Eric S. Fain, M.D., 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.”

Source: St.Jude Medical Inc., Business Wire