The FDA approved a clinical trial of Biotronik‘s Entovis MRI-safe pacemaker, granting an investigational device exemption to the German medical device company.
Biotronik said it’s already enrolling subjects for the 245-patient trial, which will aim to determine the safety and efficacy of the device during MRI scans.
"We are excited about demonstrating the safety of our pacemakers in the MRI environment," vice president of clinical studies Kevin Mitchell said in prepared remarks. "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."
Biotronik said the ProMRI trial will be the 1st of several planned "to obtain safety and effectiveness data for its complete portfolio of cardiac rhythm devices with MRI conditional labeling, which the company intends to submit to review for approval by the FDA," according to a press release.
