St Jude Medical, a global medical device company, today 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.
According to the company, unlike MRI-labelled devices currently available, the Accent MRI pacemaker is the only commercially available system with labelling that allows patients to undergo full-body, high-resolution magnetic resonance imaging (MRI) scans to accommodate their current and future medical needs.
Commenting on the Accent MRI pacemaker, Toshiko Nakai, assistant professor of the Nihon University School of Medicine in 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 6millimeter 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 labelling 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, according to a company, 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. Pressing the button on the handheld MRI Activator device can programme 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 memory of the Accent MRI pacemaker. The MRI Activator can then programme the device back to its original parameters after the scan has been completed.
Built on the Tendril lead platform, the pacing lead-according to the release- offers unique capabilities for safe, full-power MRI scanning, including 6F proximal lead body diameter and excellent handling characteristics. The lead features Optimlead 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.
Additionally, the Accent MRI pacemaker features an advanced pacing platform that offers wireless telemetry and algorithms to address individual patient conditions, with the added benefit 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 VIPalgorithm 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 which 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 elderly, hypertensive patients without any history of atrial fibrillation. Results demonstrated that pacemaker patients who have no history of atrial tachycardia or atrial fibrillation, 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 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.