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.
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.
In February medtech giant and Boston Scientific rival Medtronic (NYSE:MDT) won FDA approval for its Advisa DR MRI SureScan pacing system, planning to launch commercial efforts immediately.
Minnesota-based Medtronic has been touring its MRI-safe implants in the European Union and in Japan. Euro regulators recently approved Medtronic’s neurostimulation implants for compatibility with full-body MRI scanning.
Also in February German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants. Just a month later Biotronik announced that it’s planning a mid-year launch for its Iforia MRI-safe pacemaker, which just won EU regulatory approval.