Medtronic starts shipping MRI-safe pacemaker in US
17 Feb 2011
Medtronic, Inc. has announced the immediate availability in
the US of its Revo MRI SureScan MRI-safe pacemaker, following FDA
This is the first MRI-safe system in the US. However, Medtronic's
EnRhythm MRI SureScan pacemaker has been available in Europe since
2008. The company bought patents for making medical devices safe for
use with MRI scanners from Biophan Technologies in 2007.
The strong magnetic fields in MRI scanners can affect pacemakers
and injure the patient. Each year, an estimated 200,000 pacemaker
patients in the United States have to forgo MRI scans.
“The new Revo MRI pacemaker is a major technological breakthrough
for patients who need access to MRI,” said Dr J Rod Gimbel of
Cardiology Associates of East Tennessee in Knoxville, Tenn.
“Providing pacemaker patients with access to MRI allows detection
and treatment of serious medical conditions such as stroke, cancer,
and a wide variety of important neurologic and orthopaedic
“For the first time, patients will have access to a
state-of-the-art pacemaker that is designed to work safely and
effectively in an MRI environment,” said Pat Mackin, president of
the Cardiac Rhythm Disease Management business and senior vice
president at Medtronic. “This milestone underscores Medtronic’s
ongoing commitment to develop pacemaker technology that provides
meaningful differences in patients’ lives.”
Prior to the introduction of Revo MRI, pacemaker patients could
face serious complications if they were exposed to the powerful
magnetic fields generated by MRI machines, which can be as much as
30,000 times more powerful than the Earth’s magnetic field.
Complications to exposure could include interference with
pacemaker operation, damage to system components, or a change in
pacing capture threshold, which is the minimum amount of current
required to evoke a cardiac contraction.
The Revo MRI pacemaker system includes hardware modifications to
the device and leads that are designed to reduce or eliminate
several hazards produced by the MRI environment. In addition, since
MRI scanners may cause other current pacemakers to misinterpret
MRI-generated electrical noise and withhold pacing therapy or
deliver unnecessary pacing therapy, this new pacemaker includes a
proprietary SureScan feature that sets the device into an
appropriate mode for the MRI environment.
When programmed into SureScan mode prior to an MRI scan, the Revo
MRI pacemaker is designed to be safe for the MRI environment when
used per the specified MR 'Conditions for Use'. Revo MRI is
considered MR-Conditional, a term used to indicate that a device may
be used in the MRI environment under certain conditions, such as a
particular type of MRI scanner and scanner settings.