Medtronic plc has received CE Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans.
Background
Data suggests that as many as 40 percent of CRT patients will need an MRI within four years after receiving a device. This statistic has driven recent developments from several companies in supporting the use of CRT-Ds in an MRI environment, prior to which the concern was potential interaction between the MRI and the device function, with the obvious attendant risk to the patient.
It’s estimated that thousands of heart failure patients have been prevented from receiving an MRI scan, effectively denying them an important imaging technology used by doctors to diagnose conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and joint pain.
The European marketing clearance means CRT-D patients now have access to the most advanced imaging diagnostic procedures available. This full line of CRT-Ds is now available in Europe to help treat heart failure and reduce the risk of sudden cardiac arrest in patients with a range of Medtconic’s systems encompassing Claria MRI(TM) Quad CRT-D SureScan(TM), Amplia MRI(TM) Quad CRT-D SureScan(TM) and Compia MRI(TM) Quad CRT-D SureScan(TM). All three CRT-Ds are approved for MRI scans without positioning restrictions.
Physician comments
“The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives,” said Prof. 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.”
Company comments
“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 3T MR-conditional pacemakers, ICMs, ICDs and CRT-Ds in Europe.”
Source: Medtronic, plc
published: February 22, 2016 in: Approval/Clearance, Cardio, Imaging, Medtronic