Medtronic Receives CE Mark for Ensura MRI(TM) SureScan(TM) Pacing System Approved for Use in MRI Machines as Labeled

MINNEAPOLIS, Jun 30, 2010 (BUSINESS WIRE) -- Medtronic, Inc. /quotes/comstock/13*!mdt/quotes/nls/mdt (MDT 36.68, +0.48, +1.33%) announced today the company received CE (Conformite Europeenne) Mark for Ensura MRI(TM) SureScan(TM) pacing system. Ensura MRI is the company's new option in the second-generation pacing system, available in select European geographies, in a portfolio of devices from Medtronic designed, tested, and approved for use as labeled 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.

"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.

source: Medtronic

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