Boston Scientific begins SAMURAI trial to evaluate new pacing system in MRI environment


On 15 April, Boston Scientific announced that the first patient has been implanted with the next generation ImageReady MR Conditional pacing system (Boston Scientific) in the SAMURAI clinical trial.

The next generation ImageReady pacing system is comprised of the Boston Scientific Ingenio MRI pacemaker family and the new Ingevity MRI pacing leads. According to a company release, the proprietary technology is aimed at reducing MRI interference with device performance. In addition, the Ingevity pacing lead platform is designed to provide key enhancements in handling and fixation compared to standard leads available today, and is specifically engineered to function in the MRI environment.

“Physicians are very limited in device options and therapies labeled for use in the MRI setting,” said Ronald Berger, professor of Medicine, Johns Hopkins Medical Institutions, USA. “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 Ingenio MRI pacemaker family also offers pacing technologies not previously available in devices designed for the MRI environment.”

The SAMURAI trial is a prospective, open-label, two-group randomised, multicentre, global clinical study designed to support FDA regulatory approval of the ImageReady pacing system. The trial is expected to enrol approximately 363 patients at 45 centres in seven countries.

The company announced that the first patient implant in the United States occurred at OhioHealth’s Riverside Methodist Hospital in Columbus, Ohio by Sreedhar Billakanty, co-investigator of the SAMURAI study at OhioHealth along with Gregory Kidwell, system medical director of Electrophysiology Services. The first study implant in the world occurred in Malaysia at the Institut Jantung Negara (Kuala Lumpur) by Razali Omar.

The ImageReady pacing system is under clinical investigation and not currently available for sale in the United States.