Medtronic receives CE mark for three MRI-compatible cardiac resynchronisation therapy defibrillators



Medtronic has received CE mark for cardiac resynchronisation defibrillators (CRT-Ds) which are approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans. These devices are the first and only CRT-Ds approved for this level of MRI, according to a company release.

This full line of CRT-Ds-also labelled for 1.5T scanners-is now available in Europe to help treat heart failure and reduce the risk of sudden cardiac arrest in patients. It includes the Claria MRI Quad CRT-D SureScan, the Amplia MRI Quad CRT-D SureScan and the Compia MRI Quad CRT-D SureScan systems. All three CRT-Ds are approved in Europe 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,” says J Schwitter, cardiologist and director of the Cardiac MR Center at the University Hospital Lausanne, Switzerland. “The most common magnetic field strength for an MRI is 1.5T, 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.”

The Claria MRI CRT-D features the EffectivCRT Diagnostic and the EffectivCRT algorithm, which automatically adjusts pacing rates during atrial fibrillation-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 AdaptivCRT algorithm, which has been shown to improve CRT response rate by 12%, and to reduce risk of atrial fibrillation by 46% compared to echo-optimised biventricular pacing. They also enable Multiple Point Pacing, which can stimulate two sites on the left ventricle simultaneously.

Additional features available in all three devices include:

  • Attain Perfoma MRI SureScan Quadripolar Leads: Attain Perfoma left ventricular leads include short bipolar spacing to reduce phrenic nerve stimulation (PNS) occurrence; steroid on all electrodes; and three shapes for varying patient anatomies.
  • VectorExpress Technology: An automated in-office test that is designed to reduce lead programing to two minutes, and reveal clinically actionable information to help physicians select optimal pacing configurations for each patient.

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 3T MRI machines in Europe. These include: Advisa MRI and Ensura MRI pacemakers, Micra transcatheter pacing system, Reveal XT and Reveal LINQ insertable cardiac monitors, and Evera MRIand Visia AF MRI implantable cardioverter defibrillators.