St Jude Medical’s Accent MRI pacemaker and Tendril MRI lead have received European CE mark approval.
The system, designed for use in a magnetic resonance imaging (MRI) environment and approved as MR-Conditional, allows patients to undergo full-body, high-resolution MRI scans.
A single button press on the handheld MRI Activator device can be used to program the specific device parameters to be used during the MRI scan.
The parameters are pre-selected by the patient’s physician and stored in the Accent MRI pacemaker.
The MRI Activator can then be used to program the device back to its original settings after the scan has been completed.
The InvisiLink telemetry feature of the Accent MRI pacemaker system enables wireless communication between the implanted device and the programmer used by the clinician.
Wireless communication can be performed in the office or through remote monitoring via the Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system.
The Accent MRI pacemaker has other features including AutoCapture Pacing System technology that measures the heart’s reaction to pacing beat-by-beat, and the VIP algorithm that enables the heart’s intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.
The Tendril MRI pacing lead, built on the Tendril lead platform, offers design advantages for safe, MR-Conditional scanning.
In addition, the lead features Optim lead insulation, which is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.