Temple University Hospital Offering New FDA Approved Implantable Defibrillator

Temple University Hospital is the first hospital in the region to offer patients a new FDA approved implantable cardioverter defibrillator (ICD) system that is acceptable for use with magnetic resonance imaging (MRI) scans. Until now, patients who have an ICD implanted have generally not been able to receive MRI scans because of possible interactions between the MRI and the battery-powered device, which could lead to a malfunction in the defibrillator.

"We are pleased to offer this innovative technology at Temple," said Joshua Cooper, MD, FACC, FHRS, Director of Cardiac Electrophysiology at Temple University Hospital, and Professor of Medicine at Temple University School of Medicine. "This new device could be a big deal for patients who may benefit from an ICD implantation to deliver life-saving therapy. Many of these same patients may need an MRI at some point in their lifetime and this piece of technology will help break down the barrier between ICDs and MRIs."

ICDs are used to treat sudden cardiac arrest (SCA), a condition where the heart suddenly and unexpectedly starts beating in a very rapid pattern, and can be fatal if not treated within minutes. An ICD is a small implantable heart device that is placed under the skin to keep track of a patient’s heart rate for patients who have already had, or are felt to be at risk for a sudden cardiac arrest. If an abnormal rapid heart rhythm is detected, the device will automatically deliver an electric shock to restore the heartbeat to normal.

MRI is an imaging technique that uses a strong magnetic field to create detailed pictures of the organs and tissues within a person’s body that cannot be seen with other imaging methods. MRIs are used for a wide range of medical conditions, including stroke, cancer, Alzheimer’s disease, and muscle, bone and back pain.

The Medtronic Evera MRI™ SureScan® ICD System has been FDA approved to allow for MRI scans on any part of the body because of a very low risk of interactions between the MRI and the implanted defibrillator. The approval was based on safety and efficacy data from the Evera MRI Clinical Trial. The data demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.

"This new product will not replace all defibrillators. There are other ICD models that have different features that may be more suitable for a patient's specific needs. But, this MRI-safe ICD is a great new option to have available for our patients at Temple," explained Dr. Cooper.

Editor's Note: Dr. Cooper nor any members of his immediate family has financial interest in Medtronic.