Japan Approves St. Jude MRI-Friendly Pacemakers

St. Paul, Minn.-based St. Jude Medical has received regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Accent MRI pacemakers and the Tendril MRI lead. According to the company, the Accent MRI pacemaker is the only commercially available system with labeling that allows patients to undergo full-body, high-resolution magnetic resonance imaging (MRI) scans. Usually, patients with pacemakers implanted cannot receive an MRI due to the high-powered magnets in the scanner. St. Jude is launching the products immediately in Japan.

“We are pleased to see the MRI-conditional pacemaker launched by St. Jude Medical,” said Toshiko Nakai, M.D., assistant professor of the Nihon University School of Medicine in Tokyo. “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.”

MRI scans help to 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.

“The Accent MRI pacemaker has many advantages over what is currently available for patients,” said William Phillips, senior vice president of St. Jude Medical Asia. “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.”

The system has an MRI activator device that provides an option for programming the patient’s pacemaker to the appropriate MRI mode for use during the MRI scan. The device is hand-held, and a single-press button programs 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.

The pacemaker is also wirelessly accessible through the Merlin.net Patient Care Network, a secure internet-based remote care system. Physicians can access the device remotely, claims St. Jude, and adjust its configurations according to individual patient needs.

The pacing lead includes a 6F proximal lead body diameter and features Optim lead insulation, a silicone-polyurethane, co-polymer material created specifically for cardiac lead use. The Optim insulation is designed for long-term reliability, and was St. Jude’s answer to the controversy over its Riata leads, accused of fraying and causing several deaths.

Accent MRI is available in two models: Accent MRI DR pacemaker is a dual chamber pacemaker designed to sense and pace in the atrium and ventricle (the upper and lower chambers) of the right side of the heart; and the Accent MRI SR pacemaker is a single chamber pacemaker designed to sense and pace in the right ventricle, the lower right chamber of the heart.