The first investigational scan occurred on July 7, 2014 at St. Mary Medical Center in Langhorne, Pennsylvania, according to the company.
University of Michigan Health System assistant professor and a principal investigator of the ProMRI study Dr Thomas Crawford said that frequently, patients with defibrillators need diagnostic imaging with MRI, and until now the safety of MRI imaging in those patients was questioned.
"MRI Conditional defibrillators are a major advance in cardiac devices," Dr Crawford added.
The US Food and Drug Administration (FDA) had approved an expansion of Biotronik’s ProMRI study, which consists of a series of MRI compatibility trials, to full-body scans for Iforia ICD and DX device systems in May 2014.
The Biotronik-sponsored trial has been enrolling patients in US since March 2013.
Based on data from the Phase A of the ProMRI trial, the FDA approved Biotronik’s Entovis pacemaker systems for MRI scans with an exclusion zone. Phase B, which is nearing completion, expanded the trial for pacemakers with full-body scans, including cardiac and thoracic spinal scans.
Phase C of the trial includes Iforia implantable cardioverter defibrillator (ICD) systems into the list of devices being investigated for full-body MRI scans, including the DX system.
With Biotronik’s ProMRI technology, cardiac rhythm patients can have access to MRI scanning.
The company claims that its DX ICD system 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.
Image: Biotronik location in Lake Oswego, US. Photo: Courtesy of Biotronik, Inc.
