BOSTON and LAKE OSWEGO, May 15, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced that the Phase C results of the ProMRI®
Clinical Study were presented at the Late Breaking Clinical Trial session of the Heart Rhythm 36th Annual Scientific Sessions (HRS).Dr. Khaled A. Awad, Assistant Professor of Medicine at University of Alabama-Birmingham School of Medicine, presented the findings at HRS in Boston. The completed study has been submitted to the US 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 US, of which 154 received thoracic spine (74.3%) or cardiac (25.7%) MRI scans. Of these patients, 61.7% 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.“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 Dr. 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 US 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.12
MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT) 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. With its ProMRI technology, BIOTRONIK has developed a solution that grants all cardiac-rhythm patients access to MRI scanning. 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 (NCT01761162) started US subject recruitment in March 2013.
- Morgan Stanley, ICD market, 1996–2009.
- Roguin A, et al. Europace. 2008, 10 (3).
- Investigational Device: Limited by US law to investigational use.