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.