Biotronik has obtained the US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI trial, allowing patients enrolled in Phase C of the trial to receive full-body scans, and for the first time include patients with DX implantable cardioverter defibrillators (ICDs) in the study.
Phase C of the ProMRI trial is the final phase in a series of MRI compatibility trials conducted by Biotronik in rapid succession.
Safety of the Entovis pacemaker systems during MRI scans was assessed by Phase A and Phase B of the ProMRI trial. Based on results from Phase A of the ProMRI trial, the FDA has approved the Entovis systems for MRI scans with an exclusion zone in May 2014.
Phase B expanded the ProMRI trial to assess the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans.
Biotronik is expected to submit the data from Phase B, which is nearing completion, to the FDA in the near future.
Biotronik had received CE Mark approval for its implantable cardioverter defibrillator in 2011 for use in a magnetic resonance imaging (MRI) scanner.
The ProMRI trial is the next step in making this technology widely available in the US. The Biotronik-sponsored trial has been enrolling patients since March 2013.
Biotronik claims that the DX ICD system, which was launched in the US in 2013, provides physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms with only a single lead.
Biotronik Clinical Studies vice president Kevin Mitchell said that the company is committed to extending its ProMRI technology to as many patients as possible.
"We were the first company to offer ICD patients in the U.S. MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool," Mitchell added.