Medtronic in MRI-safe pacemaker trial:
This article was originally published in Clinica
Executive Summary
Medtronic has begun an international clinical study of what it claims is the "first-ever" pacemaker to be developed and tested specifically for safe use in MRI machines under specified scanning conditions. Its EnRhythm MRI SureScan pacemaker includes modified hardware to minimise the level of energy transmitted through the lead/device connection point. It also includes a feature that can be programmed "on" before an MRI scan to eliminate the impact of MRI-generated electrical noise, which can prevent necessary pacing therapy or cause the device to over-sense and deliver unnecessary pacing therapy. The new study will involve around 350 patients and is expected to last for about 24 months. As for competitors, Pittsford, New York-based Biophan Technologies is aiming to develop biomedical devices capable of safely working with MRI systems.