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Boston embarks on MRI-safe pacemaker pivotal study

This article was originally published in Clinica

Executive Summary

Boston Scientific has taken a step closer to US approval of its ImageReady MRI-compatible pacemaker by starting a pivotal study of the device. At present, rival Medtronic is the only company to have an MRI-safe pacemaker approved in the US, where it is called Revo MRI SureScan (www.clinica.co.uk, 9 February 2011); Medtronic CE marked the device for sale in Europe in 2008, where it is known as EnRhythm MRI SureScan (www.clinica.co.uk, 27 November 2008).

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