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SAMURAI clinical trial to evaluate new pacing system in MRI environment
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The first patient in the United States has been implanted with the next-generation ImageReady MR Conditional pacing system in the SAMURAI clinical trial, according to a press release from Boston Scientific.
The trial is designed to confirm the safety and effectiveness of the pacing system in the MRI environment.
“Physicians are very limited in device options and therapies labeled for use in the MRI setting,” Ronald Berger, MD, PhD, professor of medicine at Johns Hopkins Medical Institutions, stated in the release. “The availability of a pacing system specifically designed to allow patients with pacemakers to undergo a broad set of MRI scanning conditions will advance the quality of patient care.”
The ImageReady pacing system comprises the Boston Scientific Ingenio MRI pacemaker family and Ingevity MRI pacing leads. The technology is aimed at reducing MRI interference with device performance. In addition, the Ingevity pacing lead platform is designed to provide enhancements in handling and fixation compared with standard leads, and is specifically engineered to function in the MRI setting, according to the release.
SAMURAI is a prospective, open-label, two-group, randomized, multicenter clinical study designed to support FDA regulatory approval. Researchers are expected to enroll approximately 363 patients at 45 centers in seven countries. The first US patient implant occurred at OhioHealth’s Riverside Methodist Hospital in Columbus. The first patient implant in the world occurred at Institut Jantung Negara in Kuala Lumpur, Malaysia, according to information in the release.
The ImageReady pacing system is under clinical investigation and is not currently available for sale in the United States. For more information, visit the Boston Scientific website.