Boston Scientific launches clinical trials for next-gen MRI-friendly pacemaker

April 16, 2013 by Sony Salzman

Medical device company Boston Scientific launches a new clinical study evaluating its next-generation ImageReady pacemakers, designed to reduce interference while patients undergo an MRI.

Boston Scientific

Boston Scientific (NYSE:BSX) launched a new clinical trial assessing the performance of its next-generation ImageReady MRI-friendly pacemaker, designed to reduce interference while patients undergo an MRI.

The medical device titan announced this week that the 1st patient had been treated in the company's SAMURAI clinical study, a multi-center, randomized trial that will enroll up to 363 patients at 35 centers in 7 countries. Boston Scientific plans to use the study data in FDA approval applications, according to a press release.

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The ImageReady device is essentially a fusion of Boston Scientific's Ingenio MRI pacemaker and the newer Ingevity MRI pacing leads. The company is touting the Ingevity lead platform as "specifically engineered to function in the MRI environment," according to a statement.

Boston Scientific's MRI-safe Advantio and Ingenio pacemakers with Image Ready pacing have been on the European market since winning CE Mark approval in April 2012.

The Natick, Mass.-based medical device company isn't alone in developing cardiac rhythm management systems that can withstand MRI. MRI-friendly technology has caught the eye of some of the largest cardiac implant makers in the industry.