Wireless MRI-Conditional Pacemaker Approved in Japan

Unlike the magnetic resonance imaging (MRI)-labeled devices currently available, a new MRI pacemaker is the only commercially available system with labeling that allows patients to undergo full-body, high-resolution MRI scanning to provide for their current and future medical requirements.

St. Jude Medical, Inc. (St. Paul, MN, USA), a global medical device company, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), and launch of the Accent MRI pacemaker and the Tendril MRI lead.

Commenting on the Accent MRI pacemaker, Dr. Toshiko Nakai, assistant professor of the Nihon University School of Medicine (Tokyo, Japan), said, “We are pleased to see the MRI-conditional pacemaker launched by St. Jude Medical. I believe the benefit of full-body scanning with 1.5 Tesla MRI, the 6-mm thinness and ability to provide remote monitoring together make this device patient-friendly.”

“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. We are excited to offer this innovative technology to hospitals throughout Japan,” said William Phillips, senior vice president of St. Jude Medical Asia.

The system features an MRI Activator device that provides a simple option for programming the patient’s pacemaker to the appropriate MRI mode for use during the MRI scan. By pressing only one button on the handheld MRI Activator device can program the specific device parameters to be used during the MRI scan. These parameters are preselected by the patient’s physician and stored in the memory of the Accent MRI pacemaker. The MRI Activator can then program the device back to its original parameters after the scan has been completed.

Built on the proven Tendril lead platform, the pacing lead offers unique capabilities for safe, full power MRI scanning, including 6F proximal lead body diameter and excellent handling characteristics. The lead features Optim lead insulation, the first silicone-polyurethane, copolymer material created specifically for cardiac lead use. The Optim insulation is designed for long-term effectiveness, while providing physicians with better flexibility and handling to facilitate device implantation.

Furthermore, the Accent MRI pacemaker features a sophisticated pacing platform that provides wireless telemetry and algorithms to address individual patient conditions, with the added advantage of MRI conditional scanning capability. 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 Merlin.net Patient Care Network (PCN), a secure internet-based remote care system. Also included is 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.

A clinically proven atrial arrhythmia-monitoring algorithm by St. Jude Medical is also included in the Accent MRI pacemaker to help detect arrhythmias that may increase stroke risk. The ASSERT (ASymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial) was designed to determine whether the detection of arrhythmias using pacemaker-based diagnostics predicts an increased risk of stroke in older, hypertensive patients without any history of atrial fibrillation (AF). Study findings revealed that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

Available in two different models, the Accent MRI DR pacemaker is a dual chamber pacemaker that can sense and pace in the atrium and ventricle (the upper and lower chambers) 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.

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