Approval of Expansion of Cardioverter Defibrillator Trial to Include MRI Full-Body Scans

A new magnetic resonance imaging (MRI)-compatible, implantable cardioverter defibrillators (ICDs) provide physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and sophisticated shock reduction algorithms with only one lead.

Biotronik (Berlin, Germany), a manufacturer of cardiovascular medical devices, reported that the US Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI trial. The approval will allow patients enrolled in phase C of the trial to receive full-body scans, and for the first time, include patients with DX ICDs in the study.

Biotronik, in 2011, received CE marking of approval and became the first company worldwide with an ICD approved for use in a MRI scanner. The ProMRI study is the next step in making this technology widely available in the United States. Biotronik introduced DX technology in 2013 in the United States, and it has been rapidly accepted by US electrophysiologists. Patients prefer implants with less hardware while physicians benefit from dual-chamber diagnostic data.

“With the DX system, I gain important diagnostic and therapeutic information. For my primary prevention patients with no dual chamber pacing indication, the implant procedures are straightforward, and it makes sense to use as little hardware as possible,” said Harpreet S. Grewal, MD, FACC, FHRS, from Richmond Cardiology Associates (Richmond, VA, USA). “The potential to provide this therapy and have it approved for use in full-body MRI conditions adds clinical value.”

Phase C of the ProMRI trial is the final phase in a series of 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. Phase A resulted in FDA approval on May 6, 2014, of Entovis systems for MRI scans with an exclusion zone. Phase B expanded the trial to evaluate the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans. Phase B is nearing completion and data will soon be submitted to FDA.

“We are anxiously awaiting the day when this important diagnostic capability, up to now only available to pacemaker patients, can also benefit ICD patients,” said Kevin Mitchell, vice president, clinical studies at Biotronik, Inc. “Biotronik is committed to extending its ProMRI technology to as many patients as possible. We were the first company to offer ICD patients in the United States MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool.”

Every year, about 200,000 patients in the United States are implanted with ICDs, and studies estimate that 50%–75% of them will develop a clinical need for an MRI scan during their lifetime. MRI scans frequently provide improved diagnostic capabilities for specific that cannot be adequately examined by X-ray, computed tomography (CT), or ultrasound. The strong forces applied during an MRI scan can have a negative effect on both device and patient, and are usually contraindicated for pacemaker and ICD patients.

With its ProMRI technology, Biotronik has developed a solution to enable all cardiac rhythm patients’ access to MRI scanning. ProMRI technology is already used widely in Europe, including recent CE approval for MR-Conditional full-body and 3.0 Tesla scans with the Ilesto/Iforia ICD system. The Biotronik -sponsored trial has been in US subject recruitment since March 2013.

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