Biotronik has announced that the Food and Drug Administration (FDA) has approved the expansion of the company’s ongoing ProMRI trial. The new phase of the trial (Phase C) will study Biotronik’s ProMRI technology in implantable cardioverter defibrillator (ICD) devices.
Biotronik states that this is the only company with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner.
“This technology will finally allow full diagnostic capabilities for our patients who are more likely to need MRI scans,” said Theofanie Mela, director of Pacer and ICD Clinic at Massachusetts General Hospital in Boston, USA. “MRI is a safe and reliable diagnostic technology, and demand for imaging studies is growing. ICD patients are frequently recommended for MRI scans, but until now they have been unable to receive them. We are very excited to be participating in the ProMRI trial.”
The first phase of the ProMRI trial (Phase A) evaluated the safety of the Entovis pacemaker systems during MRI scans, excluding scans in the chest area. This phase was completed on 18 November 2013, and the FDA is now conducting its review of the pre-market application. Earlier that same month, the FDA had approved Phase B of the study, which expanded the trial to evaluate the safety of these pacemaker systems during MRI scans including cardiac and thoracic spine scans. Phase B has already enrolled more than 100 of the planned 245 patients, and will continue concurrently with the newly approved ICD phase of the study.
“In the last three months, the clinical study sites have completed half of the Phase B enrolments, and I expect that momentum to continue through Phase B and as we begin Phase C,” said Kevin Mitchell, vice president, Clinical Studies at Biotronic. “There is real enthusiasm to bring this meaningful advancement to patients; it is very positive and palpable throughout the study sites.”
The latest phase of the ProMRI clinical study aims to determine whether ICD patients can safely undergo MRI scans with an exclusion zone. The study will recruit and evaluate 172 patients at 35 US investigational centres. The ICD ProMRI with exclusion zone study is designed to confirm the safety and efficacy of Biotronik’s Iforia devices, with Setrox and Linox leads during an MRI scan. All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.