Healthcare Industry News:  computed tomography 

Devices Cardiology Regulatory

 News Release - June 19, 2009

Medtronic Receives CE Mark for Second-Generation MRI Pacemaker

Advisa DR MRI SureScan Pacing System Gives Pacemaker Patients Safe Access to Critical Diagnostic Tool

MINNEAPOLIS & BERLIN--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced it has received CE (Conformité Européenne) Mark for the company’s second-generation pacemaker designed, tested, approved for use as labeled with MRI machines, the Advisa DR MRI™ SureScan™ pacing system. The Advisa MRI SureScan pacing system currently is not available for sale in the United States.

Approximately 2 million Europeans have implanted pacemakers, but these patients are strongly discouraged from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, because their device could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50-75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices1.

“Half of the world’s pacemakers that are implanted are from Medtronic, and the number one unmet need is MRI compatibility,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Previously, physicians had been forced to forego the benefits of MRI, or accept the significant risk associated with scanning device patients. Medtronic is pleased to give physicians a solution to this unmet need – in fact a choice of devices for their pacemaker patients who may need access to important diagnostics available through MRI.”

The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems: exclusives such as MVP® (Managed Ventricular Pacing), OptiVol® Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM). MVP reduces right ventricular pacing by 99 percent2. In SAVE PACe, a previous trial of pacemaker patients published in The New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation. Further, the 2008 ACC/AHA/HRS Device-Based Therapy Guidelines indicate there may be deleterious effects from even modest levels of ventricular pacing associated with alternative programming modes.

VCM and ACM are intended to automatically adjust impulses for optimal stimulation of the heart’s chambers. The device also offers enhanced diagnostics to help assist physicians in the diagnosis of irregular heart rhythms, particularly atrial tachyarrhythmia (AT) / AF. Additionally, upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink® Network.

About MRI

Magnetic resonance imaging (MRI) allows doctors to see internal organs, blood vessels, muscles, joints, tumors, areas of infection and more, without X-rays or surgery, and without exposing the patient to any ionizing radiation. The MRI machine creates a magnetic field, sends radio waves through the body, then measures the response with a computer, creating an image of the inside of the body. In many cases, MRI gives information that cannot be seen on an X-ray, ultrasound or computed tomography (CT) scan.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.

1 Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol. April 2005;28(4):326-328.

2 Gillis, AM, et al. Reducing Unnecessary Right Ventricular Pacing with the Managed Ventricular Pacing Mode in Patients with Sinus Node Disease and AV Block. PACE. July 2006; 29(7):697-705.


Source: Medtronic

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