FDA Approval for Biotronik Entovis Pacemaker System with ProMRI® Technology

Biotronik says the U.S. FDA has approved its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo MRI scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.

FDA Approves Trial Expansion of Biotronik’s MRI Compatible Pacemakers

Biotronik, a pioneer in MRI compatible Cardiovascular implants devices, tells us that the US FDA has approved an expansion of its ongoing ProMRI® trial. This will allow inclusion of additional patient cohorts into the study, providing further support for the company’s proposed claims.