Japanese Approve St.Jude’s Wireless MRI-Conditional Pacemaker

St. Jude Medical, Inc. has gained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI™ Pacemaker and the Tendril MRI™ lead. In a claim that’s likely to enrage companies like Biotronik, St. Jude’s press release pointedly claims that its Accent device uniquely allows patients to undergo full-body, high-resolution magnetic resonance imaging (MRI) scans.

Background

MRI scans are important imaging procedures as they better evaluate the presence of certain diseases and injuries that may not be adequately assessed with other imaging methods, such as X-ray or ultrasound. Patients with traditional pacing systems are discouraged from receiving MRI scans because their device may be affected, which deprives them the standard of care MRI diagnostic technology provides.

St.Jude’s 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. The press of a single button on the handheld MRI Activator device can 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 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.

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 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 VIP™ algorithm that enables the heart’s intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.

Physician comments

Commenting on the Accent MRI pacemaker, Dr. Toshiko Nakai, assistant professor of the Nihon University School of Medicine in Tokyo 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 millimeter thinness and ability to provide remote monitoring together make this device patient-friendly.”

Company comments

“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.

Source: St.Jude Medical, Inc., Business Wire