Europe Allows Medtronic CRT Defibrillators To Be Used in MRI Scans

Dublin, Ireland-based medical device giant Medtronic plc has received the CE mark for its cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available. This full line of CRT-Ds—also labeled for 1.5 T scanners—is now available in Europe to help treat heart failure and reduce the risk of sudden cardiac arrest in patients with Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D SureScan, and Compia MRI Quad CRT-D SureScan systems. All three CRT-Ds are approved for MRI scans without positioning restrictions. The Claria CRT-D is not approved for sale in the United States.

“The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives,” said J. Schwitter, M.D., cardiologist and director of the Cardiac MR Center at the University Hospital Lausanne, Switzerland. “The most common magnetic field strength for an MRI is 1.5 T, particularly for cardiac MRI; however, many institutions are installing 3 T scanners to provide increased image clarity for conditions involving the brain and spine. With expanded access to 3 T scans, physicians can now use a broader spectrum of MRI machines to most accurately diagnose critical and even life-threatening conditions.”

As many as 40 percent of CRT patients will need an MRI within four years after receiving a device. However, until the availability of MR-conditional CRT-Ds, patients with these devices were contraindicated from undergoing MRI scans because of the potential interaction between the MRI and the device function, which could result in risk to the patient. This has prevented thousands of heart failure patients from receiving an MRI scan, an important imaging technology used by doctors to diagnose conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and joint pain.

The Claria MRI CRT-D features the EffectivCRT Diagnostic and the EffectivCRT during atrial fibrillation algorithm, which automatically adjusts pacing rates—without adversely affecting the average heart rate—to tailor the therapy to individual patients.

The Claria MRI and Amplia MRI CRT-Ds also feature the Medtronic-exclusive AdaptivCRT algorithm, which has been shown to improve CRT response rate by 12 percent and to reduce risk of atrial fibrillation by 46 percent compared to echo-optimized biventricular pacing. They also enable multiple point pacing, which can stimulate two sites on the left ventricle (lower chamber) simultaneously.

In addition to the full line of CRT-Ds, Medtronic MR-conditional cardiac rhythm and heart failure devices and leads previously approved for 1.5 Tesla are now approved for full body scans in both 1.5 and 3 T MRI machines in Europe. Medtronic MR-conditional devices also include deep brain stimulation neurostimulators and spinal cord stimulators.

“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,” said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director for the Cardiac Rhythm and Heart Failure division of Medtronic. “With this latest regulatory milestone, Medtronic now provides both 1.5 and 3 T MR-conditional pacemakers, ICMs, ICDs and CRT-Ds in Europe.”