MRI-Compatible Pacing System Receives CE Mark

July 14, 2010 – Medtronic Inc. recently announced it has received CE (Conformité Européenne) Mark for the Ensura MRI SureScan pacing system. Ensura MRI is the company’s new option in a portfolio of devices from Medtronic that have been designed, tested and approved for use with MRI machines. Patients with this new SureScan pacing system will have access to full body scans, without positioning restrictions in the MRI scanner. The Ensura MRI SureScan pacing system currently is not approved for sale in the United States.

Approximately two million Europeans have implanted pacemakers; however, these patients are strongly discouraged from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, such as cancer, neurological disorders and orthopedic injuries. It is possible current pacing systems could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50 to 75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices. [1] MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scan, and critical for early detection, diagnosis and treatment.

References:

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