Biotronik, a medical device manufacturer based in Lake Oswego, Oregon, announced that the United States Food and Drug Administration has approved a trial of its ProMRI system with an Investigational Device Exemption (IDE). Biotronik will sponsor the trial and is currently looking for qualified candidates.
According to a press release by the company, the clinical trial will be used to evaluate the efficacy of the Biotronik’s single- and dual-chamber pacemakers after exposure to an MRI. Both the single- and dual-chamber pacemakers have already received 510(k) approval from the FDA. The purpose of the study is to determine if patients with Biotronik’s pacemaker systems can undergo MRIs without adverse events.
While Biotronik is not the first company to pursue MRI-friendly pacemakers, its pacemakers do include features not found on other pacemakers in its class. 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.
Kevin Mitchell is the clinical studies VP at Biotronik. In prepared remarks, he said, "We are excited about demonstrating the safety of our pacemakers in the MRI environment.” He continued, "Estimates indicate that as many as 75 percent of patients implanted with pacemakers may require an MRI scan, and we look forward to ensuring that these patients have access to the procedure with the most technologically advanced pacemaker available"