Medtronic receives CE Mark for Ensura MRI compatible pacemakers

12 July 2010

Medtronic, Inc. has been awarded the CE Mark for its Ensura MRI SureScan pacemaker system. The system is a new option in a portfolio of devices approved for use with MRI machines and available in select European countries.

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.

“We are pleased to offer physicians a third option from the world’s first portfolio of MR Conditional pacing systems with our exclusive technology for patients who may need access to the critical diagnostics available through MRI.”

“Half of the world’s pacemaker implants are from Medtronic, and physicians say 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 offer physicians a third option from the world’s first portfolio of MR Conditional pacing systems with our exclusive technology for patients who may need access to the critical diagnostics available through MRI.”

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, 50-75 percent 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 in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scans, and critical for early detection, diagnosis and treatment.