Biotronik Presents Clinical Trial Results at HRS 2015

Biotronik Inc., a manufacturer of cardiovascular medical technology, announced that the Phase C results of the ProMRI clinical study were presented at a clinical trial session of the Heart Rhythm Society (HRS) 36th annual scientific sessions in Boston, Mass.

Khaled A. Awad, M.D., assistant professor of medicine at University of Alabama-Birmingham School of Medicine, presented the findings. The completed study has been submitted to the U.S. Food and Drug Administration (FDA) to support approval of the Iforia ProMRI implantable cardioverter defibrillator (ICD) system.

A total of 170 ICD patients were enrolled at 39 clinical sites in the United States, of which 154 received thoracic spine (74.3 percent) or cardiac (25.7 percent) magnetic resonance imaging (MRI) scans. Of these patients, 61.7 percent had been implanted with the Iforia DX ICD, and the remainder with the Iforia DR-T ICD. All three of the study’s primary endpoints were met with statistical significance. Considered a critical safety endpoint, the observed change in the ventricular pacing threshold between the pre-MRI and one-month post-MRI observation period was only 0.01v. Similarly, the change in R-wave amplitude during this period was -0.47mV. There were no reports of device-related serious adverse events during the trial, according to the company.

“Like all of the investigators who have contributed, I am pleased to lead the charge to new horizons of diagnostic imaging for cardiac device patients,” said Awad. “Even cardiac imaging had no significant effect on device performance. Importantly, we had multiple patients who had spontaneous ventricular arrhythmia episodes that were appropriately detected and treated by the Iforia ICD in the post-MRI follow-up period. These life-saving devices were able to function as designed, completely unaffected by the MRI scan.”

Phase C of the ProMRI trial is the latest phase in a series of ground-breaking MRI compatibility trials conducted by Biotronik in rapid succession. Phase A and Phase B of the trial evaluated the safety of Biotronik Entovis pacemaker systems during MRI scans. Eluna and Entovis ProMRI pacemaker systems were FDA-approved for full-body MRI scans in March 2015.

“Throughout the ProMRI clinical trial, we have scanned more than 500 patients without any safety concerns,” said Kevin Mitchell, vice president, clinical studies at Biotronik Inc. “Many patients with ICDs remain unable to obtain the diagnostic procedures they need, and we look forward to removing that barrier using the evidence these investigators have gathered.”

Every year, about 200,000 patients in the U.S. are implanted with ICDs, and studies estimate that 50 to 75 percent of them will develop a clinical need for an MRI scan during their lifetime. MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography or ultrasound. The strong magnetic forces applied during an MRI scan can, however, have a negative effect on both device and patient. Therefore, pacemaker and ICD patients are usually contraindicated for MRI scans.

ProMRI technology is already widely used in Europe, where recent CE approval was given for MR conditional full-body and 3.0 tesla scans with the Ilesto/Iforia ICD system.

The Biotronik-sponsored trial started U.S. subject recruitment in March 2013.

Biotronik is headquartered in Berlin, Germany. The company’s U.S. base is in Lake Oswego, Ore.