Medtronic pacemaker system for use in MRI scanners available in Europe

26 March 2010

Medtronic, Inc. (NYSE: MDT) has announced the commercial availability of the Advisa DR MRI SureScan pacemaker in selected European geographies.

It is the company’s second-generation pacemaker in a portfolio of devices from Medtronic approved for use (as labeled) with MRI machines in selected European geographies.

Patients with this system will now have access to full body scans, without positioning limitations in the MRI scanner (it 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 published 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.