St. Jude Medical announced receiving European CE Mark approval for the Accent MRI MR-Conditional pacemaker. The implant is designed for easy programming in preparation for an MRI scan and comes with the new Tendril MRI lead.
The system features an MRI Activator(TM) device that provides a simple alternative option for programming the device to the appropriate MRI mode for use during the scan. Since it does not require a programmer, this increases both clinical and personnel efficiency. 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. These 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 Tendril MRI pacing lead, built on the proven Tendril lead platform, offers unique design advantages for safe, MR-Conditional scanning. The thin diameter makes it easier for physicians to implant, as it retains the handling characteristics of the well established Tendril platform of pacing leads. In addition, the lead features Optim(TM) lead insulation, the first silicone-polyurethane co-polymer material created specifically for cardiac lead use. The Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.
In addition, the Accent MRI pacemaker system features InvisiLink(TM) telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or through remote monitoring via the Merlin.net(R) Patient Care Network (PCN), a secure, Internet-based remote care system. The Merlin.net PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and remote transmissions sent from a patients home, allowing for more efficient and convenient care and device management, including the ability to perform a full interrogation of the pacemaker at home after the patient completes their MRI study.
The Accent MRI pacemaker has several features that simplify patient management. These features include AutoCapture(R) Pacing System technology that measures the heart’s reaction to pacing beat-by-beat, and the VIP(R) algorithm that enables the heart’s intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.