Cardiac device and remote monitoring company Biotronik, has gained U.S. FDA approval to commence its ProMRI® clinical trial under an Investigational Device Exemption (IDE). Recruitment is underway.
A sizeable proportion of the millions of patients implanted with pacemaker systems will develop a clinical need for an MRI scan during their lifetime. However, the strong forces applied during MRI have the potential to affect the pacemaker system negatively and, consequently, the patient’s safety. Biotronik has developed and markets systems that it claims are MRI compatible, and is undertaking this clinical study in order to demonstrate this compatibility in a patient setting.
The ProMRI® clinical trial is the first of several studies planned by the company to obtain safety and effectiveness data for its complete portfolio of cardiac rhythm devices with MRI conditional labelling, which the company intends to submit to review for approval by the FDA. The trial is designed to recruit 245 subjects implanted with one of Biotronik’s cardiac devices that include ProMRI® technology at 30 U.S. investigational centres. It will evaluate the Entovis dual- and single-chamber pacemaker systems after exposure to magnetic resonance imaging (MRI). These systems, which include Biotronik’s current pacing leads, are already approved in the U.S.
The trial will test the safety and effectiveness of the Entovis pacing system in patients undergoing MRI scans under predetermined conditions. The ultimate goal of the trial is to determine whether patients with these devices can safely undergo MRI scans. This could, in turn, provide access to important scanning procedures that will meet the future medical needs of patients implanted with Biotronik pacemakers.
ProMRI® investigator Leon Feldman, M.D., at Eisenhower Memorial Hospital in Rancho Mirage, California, points out that, “While Entovis is not the first pacemaker proven safe in the MRI environment, if the endpoints are met, it will be the first device that includes all the modern features and capabilities electrophysiologists expect to have available in pacemakers and leads.” Dr. Feldman implanted the first Entovis system in a U.S. patient on December 26 last year.
“We are excited about demonstrating the safety of our pacemakers in the MRI environment,” said Kevin Mitchell, Vice President of Clinical Studies for Biotronik. “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”
Source: Biotronik, Inc.