News | June 19, 2009

Medtronic Gets European Approval for Second-Generation MRI-Safe Pacemaker

June 19, 2009 – Medtronic Inc. today said it 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 U.S.

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 devices.

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 percent). 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.

For more information: www.medtronic.com

Related Content

Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy.

Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy.

Feature | Henry Ford Hospital | May 21, 2019 | Dave Fornell, Editor
Henry Ford Hospital thought leaders regularly speak at the radiation oncology and radiology conferences about new res
Videos | Radiation Therapy | May 21, 2019
This is a walk through of the ViewRay MRIdian MRI-guided radiotherapy system installed at ...
360 Photos | Magnetic Resonance Imaging (MRI) | May 17, 2019
This is a dedicated cardiac Siemens 1.5T MRI system installed at the Baylor Scott White Heart Hospital in Dallas.
Miami Cardiac and Vascular Institute Implements Philips Ingenia Ambition X 1.5T MRI
News | Magnetic Resonance Imaging (MRI) | May 17, 2019
Miami Cardiac & Vascular Institute announced the implementation of Philips’ Ingenia Ambition X 1.5T MR, the world’s...
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Magnetic Resonance Imaging (MRI) | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
Screening MRI Detects BI-RADS 3 Breast Cancer in High-risk Patients
News | MRI Breast | May 09, 2019
When appropriate, short-interval follow-up magnetic resonance imaging (MRI) can be used to identify early-stage breast...
Clinical Trial Explores Opening Blood-Brain Barrier in Fight Against Alzheimer's

Vibhor Krishna, M.D., (right) fits David Shorr with a helmet-like device used in a new clinical trial for Alzheimer’s disease at The Ohio State University Wexner Medical Center. The device uses MRI-guided imaging to deliver focused ultrasound to specific areas of the brain to open the blood-brain barrier. Image courtesy of Ohio State University Wexner Medical Center.

News | Focused Ultrasound Therapy | May 09, 2019
May 9, 2019 — A new clinical trial at The Ohio State University Wexner Medical Center and two other sites is testing