FDA Approves Expansion of Biotronik Clinical Trial

The U.S. Food and Drug Administration (FDA) has approved an expansion of Biotronik’s ongoing ProMRI trial. The trial’s first phase evaluated the safety of Biotronik’s current pacemaker systems during magnetic resonance imaging (MRI) scans excluding chest and thorax scan areas. The trial’s second phase now will evaluate the same pacemaker system during MRI scans without exclusion zones.

Several million patients currently are 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 adequately be examined by X-ray, computerized tomography or ultrasound. Since strong forces applied during MRI can have an adverse effect on both a device and patient, the test usually is not conducted on those with pacemakers.

The ProMRI clinical study aims to determine whether patients with pacemakers safely can undergo full-body MRI scans. The study will recruite and evaluate 245 patients implanted with one of Biotronik’s latest pacemaker systems at 35 U.S. investigational centers. The ProMRI expansion is designed to measure the safety and efficacy of Biotronik’s existing dual- and single-chamber Entovis pacemaker systems and Setrox 53 and 60 cm leads during an MRI scan. Though both devices are commercially available, neither is approved for use in MRIs.

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

Entovis devices include Biotronik Home Monitoring technology, which provides daily monitoring of the patient’s device. The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to improve handling and provide a stable fixation, as well as optimal electrical performance.

“The options for patients with CRM devices who need MRI scans have been very limited,” said Pamela K. Woodard, M.D., director of the Center for Clinical Imaging Research at Washington University School of Medicine in 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.”

The Biotronik-sponsored trial has been in U.S. site recruitment since March 2013.

Biotronik Inc. is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.