Medtronic gains EU approval for world's first MRI-safe pacemaker
4 December 2008
Medtronic, Inc., (NYSE: MDT) announced it has received the CE (Conformité
Européenne) mark for the first-ever MR-conditional pacemaker system, the
EnRhythm MRITM SureScan pacemaker and CapSureFix MRI SureScan pacing
leads (Model 5086MRI).
The new system was designed, tested and approved for use with
magnetic resonance imaging (MRI) under specified scanning conditions,
and is now commercially available in select European countries. Patients
receiving the EnRhythm MRI SureScan Pacing System will for the first
time be able to undergo MRI scans under certain conditions, representing
a major milestone in the evolution of implantable cardiac devices.
“MRI is an invaluable medical diagnostic tool for many common
diseases and conditions that, until now, patients with implanted
pacemakers have been prohibited from receiving,” said Alain Coudray,
M.D., Medtronic’s vice president of the Cardiac Rhythm Disease
Management business in Western Europe. “Medtronic recognizes the complex
needs of today’s patient and will continue to develop advancements in
pacemaker technology and other devices that allow patients to receive
optimal medical care.”
Approximately 2 million Europeans have implanted pacemakers, but
these patients are prohibited from receiving MRI scans, a widely
practiced diagnostic method for many common diseases and conditions,
because their device could interact with MRI machines, potentially
affecting the device or patient safety. According to estimates, 50-75%
of patients worldwide with implanted cardiac devices are expected to
need an MRI scan during the lifetime of their devices.
About the EnRhythm MRI SureScan system design
The EnRhythm MRI SureScan pacing system has undergone extensive
research and design efforts to address and mitigate interactions between
the pacing system and the MR environment.
The system includes modified hardware to minimize the level of energy
transmitted through the lead/device connection point. In addition, the
new system also includes a new SureScan feature designed to eliminate
the impact of MRI-generated electrical noise, as MRI scanners may cause
traditional pacemakers to misinterpret this noise and as a result
withhold or deliver unnecessary pacing therapy.
The device and leads also contain radiopaque marks, viewable via
x-ray, to indicate that the system is MR-conditional, a classification
indicating a medical device may be used in the MRI suite under certain
The CapSureFix MRI SureScan leads are designed to decrease the risk
of overheating during an MRI scan without limiting the ability to
conduct therapy. Safety and efficacy data on the system presented at the
recent European Society of Cardiology congress showed no MRI-related
complications, and no arrhythmia or asystole (absence of electrical
activity in the heart) during MRI scans conducted on patients in a
worldwide clinical study.
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