U-M first in state to implant MRI-compatible defibrillator

The U-M Frankel Cardiovascular Center is on the forefront of making diagnostic imaging possible for patients with cardiac implants. In August of 2014, U-M cardiologist and electrophysiologist Eric D. Good, D.O., implanted the state’s first patient with BIOTRONIK’s Iforia heart device. It’s the only implantable cardioverter-defibrillator (ICD) approved for investigational use in magnetic resonance imaging (MRI).

The device is commercially available, but is in the newest phase of the ongoing ProMRI® trial, a study that will examine ProMRI® technology in the MRI environment. “This technology is intended to allow for a full pallet of diagnostic capabilities for patients who are likely to benefit from MRI scans,” says Good.  “We are very excited to be participating in the ProMRI® trial.”

Every year, more than 300,000 people are implanted with ICD systems to regulate their heartbeat, and studies estimate that 50 percent to 75 percent will need an MRI scan in their lifetime. The strong magnetic forces applied during MRIs can potentially have a negative effect on both the device and leads, and are usually not recommended for pacemaker and ICD patients.

The ICD ProMRI® with exclusion zone study is designed to confirm the safety and efficacy of BIOTRONIK’s Iforia ICD during an MRI scan. All the devices in the study are conditionally approved by the U.S. Food and Drug Administration for use in the study, but still await full FDA approval for use in the MRI environment.

Aside from featuring ProMRI® technology, the single chamber Iforia series is one of the smallest ICDs in the world and also offers more than 11 years longevity. This improved longevity means fewer device replacements — a benefit for both patients and the health care system.

As a member of U-M’s Heart Rhythm Program, Dr. Good diagnoses and treats all types of arrhythmias, including atrial fibrillation and flutter, sick sinus syndrome, supraventricular and ventricular tachycardias,  genetic arrhythmia syndromes such as prolonged QT syndrome and a host of other complex arrhythmia conditions. The U-M Frankel CVC is a national referral center for treatment of complex arrhythmias, performing nearly 2,000 ablations each year. In 2013, our team of electrophysiologists performed more than 500 device procedures including pacemakers and ICDs.

Under an institutional research protocol, U-M electrophysiologists and cardiothoracic radiologists collaborate to perform MRIs on patients with pacemakers and ICDs produced by other manufacturers.

The latest phase of the ProMRI® clinical study will recruit and evaluate 172 patients at 35 U.S. investigational centers, including the U-M Frankel CVC. To learn more, call 888-286-4420.