FDA Approves Trial Expansion of Biotronik’s MRI Compatible Pacemakers

MRI compatibility is quite a hot topic among makers of cardiovascular devices at the moment. Clearly the ageing population for whom many such systems are intended, also suffer from other things that would ideally be diagnosed using MRI. In this context a pacemaker that can claim MRI compatibility would seem like a good idea. So thought Sorin, who’s newly CE marked pacemaker we reported on as recently as yesterday. Now Biotronik, itself a pioneer in MRI compatible CV devices, tells us that the US FDA has approved an expansion of its ongoing ProMRI® trial.

Background

Several million patients are currently implanted with pacemaker systems worldwide, and recent studies estimate that a sizeable portion of them will develop a clinical need for an MRI scan during their lifetimes. MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, CT, or ultrasound. The strong forces applied during MRI can have a negative effect on both device and patient, and are therefore contraindicated for pacemaker patients. This of course, excludes the new generation of devices which are claiming MRI compatibility of one form or another.

The ProMRI® trial’s expansion, so-called Phase B of the trial, is designed to confirm the safety and efficacy of Biotronik’s existing dual- and single-chamber Entovis pacemaker systems and pacing leads during an MRI scan. The just-completed Phase A evaluated the safety of the systems during MRI scans, but excluded chest and thorax scan areas. Phase B, will evaluate the same pacemaker system during MRI scans without exclusion zones.

The study will recruit and evaluate 245 patients implanted with one of Biotronik’s aforementioned pacemaker systems at 35 U.S. investigational centers.

Both Entovis devices are commercially available, but await FDA approval for use in the MRI environment.

Company comments

“Removal of the exclusion zone criteria for Phase B of this trial is important because we are now able to conduct heart or liver scans, as well” said Kevin Mitchell, Vice President of Clinical Studies at BIOTRONIK, Inc. “This will significantly increase the number of patients interested in study participation, thereby accelerating our progress.”

Physician comments

“The options for patients with CRM devices who need MRI scans have been very limited,” said Pamela K. Woodard, MD, Director of the Center for Clinical Imaging Research (CCIR) at Washington University School of Medicine, St. Louis, MO. “We’ve used this new system during the clinical trial so far, and for the head and pelvis it has been nearly equivalent to the scan process for non-CRM device patients. I’m very excited to see what we can learn about its full-body capabilities.”

Source: Biotronik

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