Medtronic wins CE Mark for line of MR-safe CRT-Ds

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for use with 3 Tesla MRI machines.

The approval includes Fridley, Minn.-based Medtronic’s Claria MRI quad CRT-D SureScan, Amplia MRI quad CRT-D and Compia MRI quad systems, which are also approved for lower-power 1.5 Tesla scanners.

“The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives. The most common magnetic field strength for an MRI is 1.5T, particularly for cardiac MRI; however, many institutions are installing 3T scanners to provide increased image clarity for conditions involving the brain and spine. With expanded access to 3T scans, physicians can now use a broader spectrum of MRI machines to most accurately diagnose critical and even life-threatening conditions,” J. Schwitter of Switzerland’s University Hospital Lausanne said in a press release.

The company said its full platform of cardiac rhythm and heart failure devices and leads previously approved for 1.5T scans are now cleared for full body scans in both 1.5 and 3T MRI machines in Europe.

Cleared devices include the Advisa MRI and Ensura MRI pacemaker, Micra transcatheter pacer, Reveal XT and Reveal Linq insertable cardiac monitor and the Evera MRI and Visia AFMRI implantable cardioverter defibrillators. Medtronic’s Deep Brain Stimulation neurostimulators and spinal cord stimulators are also cleared as MRI-safe devices.

“Medtronic is committed to providing patients with the most advanced MR-conditional technology available in cardiac rhythm and heart failure devices so they can have full access to essential MRI scans. With this latest regulatory milestone, Medtronic now provides both 1.5 and 3T MR-conditional pacemakers, ICMs, ICDs and CRT-Ds in Europe,” heart failure biz veep Dr. David Steinhaus said in a prepared statement.

Earlier this month, Medtronic claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans.

The medical device giant said the FDA approved its Amplia and Compia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to have the heart failure devices on the market “in the coming months,” according to a press release.

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