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.

Europe-wide Release for Biotronik’s Passeo-18 Lux Peripheral Vascular Drug-Releasing Balloon

Cardiovascular device company Biotronik is in the news again with the announcement of its release of the Passeo-18 Lux Drug Releasing Balloon (DRB) in all countries accepting CE mark, following recent CE approval.

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.