St. Jude Medical, Inc. (NYSE:STJ), 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. Unlike MRI-labeled devices currently available, 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 1 to accommodate their current and future medical needs.
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.”
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.
"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. 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. 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, 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 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 which may increase stroke risk. The ASSERT, or 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 (AF). Results demonstrated 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. Each year, an estimated 1.25 million pacemakers are implanted worldwide. Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. About St. Jude Medical St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 30, 2013. 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