Biotronik has received 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 include patients with DX implantable cardioverter defibrillators (ICDs) in the study for the first time.
ProMRI trial’s Phase C is the final phase in a series of MRI compatibility trials conducted by the company in rapid succession. Phase A and Phase B of the ProMRI trial assessed safety of the Entovis pacemaker systems during MRI scans.
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.
Nearing completion, 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 data from Phase B to the FDA in the near future.
Biotronik obtained 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, 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 US MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool," Mitchell said.
Image: Biotronik’s Entovis single-chamber pacemaker with ProMRI technology. Photo: courtesy of Biotronik, Inc.