EU gives nod to St. Jude's MRI pacemaker

Kaitlyn Dmyterko | | Health Exec | Precision Medicine
St. Jude Medical’s Accent MRI pacemaker and Tendril MRI lead have been granted a CE mark. The systems are approved as MR-Conditional and allow patients to undergo full-body MRI scans.

St. Paul, Minn.-based St. Jude said the technology uses an MRI Activator device that provides an option for programming the device to the appropriate MRI mode during the scan. The software does not require a programmer and can be activated with a single button on the handheld device during the scan. The device parameters are pre-selected by the patient’s physicians and stored into the MRI pacemaker and then Activator can be used to program the device back to the original settings after the patient undergoes the scan.

In addition, St. Jude said the lead also houses the Optim lead insulation, a silicone-polyurethane co-polymer material for cardiac use.

The Accent MRI pacemaker features InvisiLink telemetry that provides a connection between the device and the clinician, which is used during follow-up appointments either at the office or via remote home monitoring. Lastly, the Accent MRI pacemaker features the AutoCapture Pacing System to measure heart reaction to pacing beat-by-beat.

Kaitlyn Dmyterko

Related Content

Pitching the business case for 3D printing labs in radiology
FDA issues first-ever clearance for OTC oximeter
Augmented reality company secures $15M in funding from Cleveland Clinic, Mayo, GE Healthcare and more
Merck to acquire Prometheus Biosciences for $10.8B
Johnson & Johnson scraps RSV vaccine after trial
Intermountain Health launches new biotech company

Around the web

AI in Healthcare
4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

Cardiovascular Business
FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

Cardiovascular Business
Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.