Imricor Medical Systems announced today the completion of enrolment for the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter under real-time magnetic resonance imaging (MRI) guidance. The single-centre study enrolled 35 patients and was sponsored by the University of Leipzig Heart Center in Leipzig, Germany. Gerhard Hindricks, head of the department of Electrophysiology at the Leipzig Heart Center, was the principal investigator.
“This clinical study marks an important step in the advancement of electrophysiology (EP) interventions in the MRI environment,” said Hindricks. “We truly believe that ablating in the MRI adds substantial benefits to our standard procedures. For example, during one procedure, we were able to visualise with MR an abnormality in the patient’s heart and modify our catheter placement to successfully complete the ablation. In a traditional lab, this would have been a “difficult” procedure and we would not have known why, but with MR, we were able to see the anatomical challenges and tailor the ablation. This is quite exciting.”
Imricor’s Vision-MR catheter, when used with the Advantage-MR EP Recorder/Stimulator System, allows physicians to perform cardiac ablations under MRI guidance. With real-time MRI, physicians can individualise the ablation for each patient’s unique cardiac structure and substrate. In addition, they can assess lesion quality and fill gaps in the ablation line during the initial procedure. Ablations guided by MRI have the potential to improve outcomes and provide safer, more cost-effective treatment—all in an environment that is free of radiation for both the patient and physician.
Imricor Medical Systems recently announced its contract for up to US$2.4 million from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop an MR compatible injection catheter for MRI-guided procedures. The ten month contract which has a two-year option period will support the continued advancement of real-time MRI guided interventions for the treatment of cardiac arrhythmias.