LAKE OSWEGO, Oregon, January 22, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the first patients have been enrolled in an expansion of their ongoingProMRI trial.Phase A of the study evaluated the safety of current BIOTRONIK pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area, and was completed on November 18, 2013, just as the Food and Drug Administration (FDA) granted approval for Phase B. Now, Phase B will evaluate the safety of these pacemaker systems during MRI scans including cardiac or thoracic spine scans."We are excited that Phase B of the ProMRI study has started so quickly,” said Kevin Mitchell, Vice President of Clinical Studies at BIOTRONIK, Inc. “There are currently limited options allowing MRI scans of the thoracic region, so our clinical sites are very enthusiastic about this new phase of the trial."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 a MRI scan during their lifetimes.12
MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (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.The ProMRI clinical study aims to determine whether device patients can safely undergo full-body MRI scans. The study will recruit and evaluate 245 patients at 35 U.S. investigational centers. The ProMRI full body scan expansion is designed to confirm the safety and efficacy of BIOTRONIK’s existing dual- and single-chamber Entovis pacemaker systems and Setrox leads during a MRI scan. Both devices are commercially available, but still await FDA approval for use in the MRI environment.Entovis devices include BIOTRONIK Home Monitoring®
technology, which provides daily monitoring of the patient’s device, and are renowned for their ability to provide the most advanced physiological therapy available via BIOTRONIK Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to provide excellent handling and stable fixation, as well as optimalelectrical performance.The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
- Morgan Stanley, ICD market, 1996–2009.
- Roguin et al., Europace (2008): 10, 336-346.