News | March 05, 2015

Biotronik Concludes Enrollment in Phase C of ProMRI ICD Study

Studies validate safety of ProMRI implantable cardioverter defibrillator devices in patients subjected to head and lower lumbar 1.5T MRI scans

Biotronik, ProMRI, AFFIRM, trial, ICD, MRI systems, EP Lab

March 5, 2015 – Biotronik announced that its ProMRI and ProMRI AFFIRM studies have been published in Heart Rhythm, the official journal of the Heart Rhythm Society, validating the safety testing of Biotronik’s ProMRI technology.

Historically, device patients have been contraindicated for magnetic resonance imaging (MRIs), which are the gold standard for soft tissue diagnostics and avoid the radiation risks of computed tomography (CT) scans. ProMRI systems are approved as MR-conditional and enable access to this technology for the growing number of patients requiring an MRI.

The results of these prospective, multi-center studies provided evidence of the clinical safety of Biotronik’s ProMRI Evia/Entovis SR-T and DR-T pacemaker systems with Setrox/Safio S 53 cm/60 cm leads, when used in head and lower lumbar 1.5T MRI scanning.

These systems have already been approved for use in CE regions.

The ProMRI (United States) and ProMRI AFFIRM (Europe) studies were of identical design and enrolled 272 patients at 37 sites from October 2012 to November 2013. Device interrogation was performed at enrollment, pre- and post-MRI scan, and one- and three-months post-MRI. A total of 226 patients who completed the MRI and one-month post-MRI follow-up were included in the analysis.

The combined studies saw no serious adverse device effects observed. The pacing threshold and sensing amplitude changes from immediately before the MRI to the one-month post-MRI visit were stable and unchanged. There was no evidence of adverse impact on either the patient or the pacemaker system caused by MRI scanning.

“The results confirm the safety and reliability of BIOTRONIK’s ProMRI devices in clinical practice,” commented study author William M. Bailey, M.D., Louisiana Heart Rhythm Specialists. “MRIs are now a fairly common diagnostic tool and the likelihood that cardiac implantable electronic device (CIED) patients will require one at some point increases with the aging population. ProMRI devices are therefore the obvious choice for physicians and patients alike,” he continued.

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