Biotronik obtains FDA approval to expand ProMRI clinical trial

21 November 2013 (Last Updated November 21st, 2013 18:30)

German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI trial.

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German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI trial.

The ProMRI clinical trial is designed to evaluate Entovis dual and single-chamber pacemaker systems after exposure to magnetic resonance imaging (MRI).

These systems, which include Biotronik's Setrox 53cm and 60cm leads, are already approved in the US.

The just-completed Phase A of the trial assessed the safety of Biotronik's current pacemaker systems during magnetic resonance imaging (MRI) scans excluding chest and thorax scan areas.

The company also received the FDA approval to begin Phase B, which will evaluate the same pacemaker system during MRI scans without exclusion zones.

The trial will test the safety and effectiveness of the Entovis pacing system and Setrox 53cm and 60cm leads in patients undergoing MRI scans under predetermined conditions. Its primary objective is to determine whether patients with these devices can safely undergo MRI scans.

The study will recruit and evaluate 245 patients implanted with one of Biotronik's latest pacemaker systems at 35 US investigational centres.

Recently published studies projected that a sizeable portion of patients implanted with pacemakers may require an MRI scan during their lifetimes.

However, the strong forces applied during MRI have the potential to affect the pacemaker system negatively and consequently the patient's safety. As a result, these diagnostic scans currently are not recommended in patients with a pacemaker.

"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. This will significantly increase the number of patients interested in study participation, accelerating our progress."

MRI scanning often provides improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by other imaging modalities such as X-ray, computerised tomography (CT), or ultrasound, meaning that MRI compatible pacemaker systems are essential to comprehensive medical care.

Biotronik clinical studies vice-president Kevin Mitchell said: "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. This will significantly increase the number of patients interested in study participation, thereby accelerating our progress."

With closed loop stimulation and home monitoring technologies, Biotronik's pacemakers have a fractal coating, steroid elution and a flexible distal end to promote proper handling and optimal fixation.

Washington University School of medicine director of the Center for Clinical Imaging Research (CCIR) St Louis, Dr Pamela K Woodard said the options for patients with CRM devices who need MRI scans have been very limited.

"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."

The Biotronik-sponsored trial (NCT01761162) has been in US site recruitment since.


Image: ProMRI now with full-body scan technology. Photo: courtesy of Biotronik SE & Co KG.