MR-Conditional Pacemaker System Approved in Japan

MRI is the standard of care in soft tissue imaging, providing data not seen with X-ray, computed tomography (CT) or ultrasound scan, and critical for early detection, diagnosis, and treatment. Medtronic, Inc. (Minneapolis, MN, USA), announced the Japanese regulatory approval and launch of the Advisa DR MRI SureScan pacing system. The Advisa MRI system is the first and only MR-conditional pacemaker available to patients in Japan, the world’s second largest market for medical devices.

Advisa MRI was exclusively assessed and approved for use as labeled with MRI scanners in Japan. The system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, which must be used in tandem. “Until recently there was a significant unmet need for patients with pacemakers to have access to MRI technology,” said Ken Okumura MD, professor and chief, department of cardiology, Graduate School of Medicine, Hirosaki University (Aomori, Japan) and president of the Japanese Heart Rhythm Society. “Now physicians and patients have a choice of pacing systems that allow access to the invaluable benefits of MRI technology.”

The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by extensive computer modeling and clinical studies, as well as real-life data. Up to now, Medtronic has sold almost 100,000 SureScan devices worldwide, and thousands of SureScan patients have been able to safely undergo an MRI that would have been denied to them with a conventional pacemaker.

About 400,000 people in Japan have implanted pacemakers. However, until the availability of Medtronic's SureScan pacing systems, patients with pacemakers have been contraindicated in Japan from receiving MRI scans. There is the possibility for pacemakers to interact with MRI units in a way that could undesirably affect the device function or patient safety. According to estimates, 50%-75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

The Advisa DR MRI SureScan pacing system is not yet available in the United States. The Revo MRI SureScan pacing system was US Food and Drug Administration (FDA) approved in February 2011.

The MRI pacing system provides patients with dedicated technology, including the MVP (managed ventricular pacing) algorithm, which is shown to reduce unnecessary ventricular pacing by 99%. Additional features include (1) complete automaticity with ventricular and atrial capture management (VCM and ACM) and antitachycardia pacing (ATP). (2) Diagnostic tools such as the Cardiac Compass Report and tachyarrhythmia management tools that assist in the early detection of atrial fibrillation (AF). (3) Remote follow-up via Medtronic’s CareLink Network, which transmits detailed arrhythmia and diagnostic device data to a doctor’s clinic. (4) Lastly, a rate drop response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may decrease the frequency of syncopal episodes in patients with apparent cardio-inhibitory vasovagal syncope.

In collaboration with leading researchers, clinicians, and scientists worldwide, Medtronic provides a wide range of medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

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