Clinical data demonstrating the safety and efficacy of Biotronik’s ProMRI pacemakers has been presented. William M Bailey, medical director of Louisiana Heart Rhythm Specialists in Lafayette, USA, discussed these results at the American College of Cardiology’s (ACC) 64th Annual Scientific Sessions (14–16 March, San Diego, USA).
At the ACC poster session, Bailey reported that ProMRI pacemakers can safely be used in a magnetic resonance imaging (MRI) environment. They were shown to be free of significant threshold increases, significant decreases in amplitude and serious adverse effects one month post-MRI. Two hundred and three patients enrolled in the ProMRI phase B study underwent full-body MRI scans, including cardiac and thoracic spinal scans, without an exclusion zone.
“I am glad to present the latest in a growing body of data that supports the safety and efficacy of ProMRI pacemakers in the MRI environment,” commented Bailey. “Pacing devices approved for use with MRI scans will lead to crucial clinical benefits for patients.”
Additional data revealed at the congress show that clinically useful diagnostic image quality can be obtained when pacemaker patients undergo cardiac or thoracic spine 1.5 tesla MRI scans. Researchers analysed the 203 MRI scans from the ProMRI phase B study for image artifacts, defined as any features that appear in an image but are not present in the original imaged object. They found that 96.1% of the images had no artifact or contained an artifact which did not affect diagnostic image quality.