Medtronic announced on 17 March 2010 the commercial availability of the Advisa DR MRI SureScan pacemaker in selected European geographies. The Advisa DR MRI SureScan pacemaker is the company’s second-generation pacemaker in a portfolio of devices from Medtronic designed, tested, and approved for use as labeled with MRI machines in selected European geographies.
Patients with the Advisa DR MRI SureScan pacing system will now have access to full body scans, without positioning limitations in the MRI scanner. The Advisa DR MRI SureScan pacing system currently is not approved for sale in the United States.
“Half of the world’s pacemakers 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. “We are pleased to now offer physicians a choice from the world’s first and only portfolio of MRI-compatible devices for patients who may need access to the critical diagnostics available through MRI.”
Approximately two million Europeans have implanted pacemakers. However, until the availability of Medtronic SureScan pacing systems, patients with pacemakers have been strongly discouraged from receiving MRI scans. There is the potential for pacemakers to interact with MRI machines in a manner that could affect the device function or patient safety. According to estimates, 50–75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.
MRI is the standard of care for soft tissue imaging, providing information not available with X-ray, ultrasound, or CT scan, and is critical for early detection, diagnosis and treatment of common diseases and conditions, such as cancer, neurological disorders and orthopaedic injuries.
Medtronic’s most advanced pacemaker provides patients with innovative exclusive technology, such as MVP (Managed Ventricular Pacing), which is proven to reduce unnecessary ventricular pacing by 99%, and complete automaticity, including Ventricular and Atrial Capture Management (VCM and ACM) and Sensing Assurance. The Advisa MRI device includes sophisticated therapies such as anti-tachycardia pacing and diagnostics such as the Cardiac Compass Report and tachyarrhythmia management tools that assist in the early detection and termination of atrial fibrillation.
The Advisa MRI device offers remote follow-up via the Medtronic CareLink Network, which transmits comprehensive arrhythmia and diagnostic device data to a physician’s clinic. In addition, the Advisa MRI pacemaker features OptiVol Fluid Status Monitoring, which, together with the Heart Failure Management Report, tracks and reports fluid changes using intrathoracic impedance measurements. These measurements may be used to detect potential fluid buildup before heart failure symptoms appear and also are available on Medtronic CareLink Network, enabling a fluid status check from a patient’s home.
Other therapies provided by the Advisa MRI device include the Rate Drop Response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may reduce the frequency of syncopal episodes in patients with apparent cardioinhibitory vasovagal syncope. The Advisa MRI device also provides high upper tracking rates up to 210 beats per minute, which may be beneficial for paediatric patients, as well as older active patients.
