LAKE OSWEGO, Oregon, June 15, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the Phase C results of the ProMRI® Clinical Study have been published in HeartRhythm, the official journal of the Heart Rhythm Society (HRS) and the Cardiac Electrophysiological Society (CES).Currently, no implantable cardioverter defibrillators (ICDs) are approved by the FDA for use in magnetic resonance imaging (MRI) scanners in the U.S. BIOTRONIK is one of two companies who have completed and published studies on ICD systems designed for MRI use. MRI-conditional ICDs were a key topic at the recent HRS Annual Scientific Session May 13-16, 2015, in Boston.Dr. Khaled A. Awad, Assistant Professor of Medicine at the University of Alabama-Birmingham School of Medicine, presented findings from the Phase C results at HRS 2015 meeting in Boston. The completed study has been submitted to the U.S. Food and Drug Administration (FDA) to support approval of the Iforia ProMRI ICD system.A total of 170 ICD patients were enrolled at 39 clinical sites in the U.S., of which 154 received thoracic spine or cardiac MRI scans. More than half (61.7%) of these patients had been implanted with the Iforia DX ICD – the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialized defibrillator lead ‑ and the remainder with the Iforia DR-T ICD. All three of the study’s primary endpoints were met with statistical significance, with nominal changes in the ventricular pacing threshold (0.01v) between the pre-MRI and one-month post-MRI observation period, and also for the R-wave amplitude change (-0.47mV); and there were no reports of device-related serious adverse events during the trial.“From the conversations and meetings I had at HRS, electrophysiologists are eager to make these devices available to patients,” said Dr. Awad. “Now that the results are published, we can all see the evidence on the safety of these particular systems.”“The interest in having ICDs approved for use in MRI scans has accelerated dramatically now that evidence is available from trials like ProMRI. All of our efforts now will be applied to working with the FDA to support their review of the findings,” said Kevin Mitchell, Vice President, Clinical Studies at BIOTRONIK, Inc. “Making this technology available to U.S. patients is our top priority.”Some in the medical community dispute the need for FDA approval of MR-conditional ICD systems, based on the results of the MagnaSafe Study. However, without FDA approval, many patients with implanted devices will either be denied MRI scans by hospitals, or will find that completed scans are not covered by their insurance carriers. The result can be costly out-of-pocket expenses for the patient.“The question I ask myself is, why make decisions today that may expose patients, physicians or hospitals to unnecessary risks or financial imposition?” said Dr. Rod S. Passman, professor of Cardiology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr. Passman recently participated in a debate on this topic at the HRS Annual Scientific Sessions.“Pacemakers proven conditionally safe for use in MRI scans are available now, and studies on ICDs have been completed and submitted for approval,” said Dr. Passman, “Physicians can ensure safe access to future MRI scans for pacemaker patients now, and apparently that option will soon be available for ICD patients as well. Even though it’s possible to scan non-proven devices, I would have to be convinced that there is a good reason to subject future patients to this unnecessary risk.”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.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 U.S. subject recruitment in March 2013.
- Morgan Stanley, ICD market, 1996–2009.
- Roguin A, et al. Europace. 2008, 10 (3).
- Investigational Device: Limited by U.S. law to investigational use.