St. Jude Medical, a US-based medical technology and services developer, has received Japanese Ministry of Health, Labor and Welfare (MHLW) clearance for the launch of Accent MRI Pacemaker and the Tendril MRI lead.
The Accent MRI pacemaker is claimed to be the only commercially available system with labeling that allows patients to undergo full-body and magnetic resonance imaging (MRI) scans.
The system has an MRI Activator device that provides a simple option for programming the patient’s pacemaker to the right MRI mode for use during the MRI scan.
With the press of a single button on the handheld MRI Activator device, the particular device parameters to be used during the MRI scan can be programed.
These parameters can be selected by the patient’s doctor and then stored in the memory of the Accent MRI pacemaker. The MRI Activator will later program the device back to its original parameters once the scan is done.
St. Jude Medical Asia senior vice president William Phillips said the Accent MRI pacemaker has many advantages over what is currently available for patients.
"The sophisticated pacemaker functionality and labeling of full-body MRI scans are especially important for patients who may need an MRI scan in the chest and abdominal area," Phillips added.
Developed on the Tendril lead platform, the pacing lead is claimed to offer capabilities for safe, full power MRI scanning, including 6F proximal lead body diameter and handling characteristics.
The lead features Optim lead insulation, a silicone-polyurethane, co-polymer material meant for cardiac lead use. Designed for long-term reliability, the Optim insulation offers physicians with better flexibility and handling to facilitate device implantation.
Moreover, the Accent MRI pacemaker comes with an advanced pacing platform that offers wireless telemetry and algorithms in order to address conditions of individual patients. It also provides the added benefit of MRI conditional scanning capability.
It comes in two different models. The Accent MRI DR pacemaker is a dual chamber pacemaker that can sense and pace in the atrium and ventricle of the right side of the heart. The Accent MRI SR pacemaker is a single chamber pacemaker that can sense and pace in the right ventricle, the lower right chamber of the heart.
Every year, about 1.25 million pacemakers are implanted worldwide. Cardiac pacemakers are used to treat bradycardia, a condition where the heart rate is too slow.