Boston Scientific has announced that the first patient in the United States has been implanted with the Boston Scientific Corporation ImageReady(TM) MR Conditional pacing system in the SAMURAI clinical trial.
The study is designed to confirm the safety and effectiveness of the system in the magnetic resonance imaging (MRI) environment. Pacing systems are designed to treat bradycardia, a condition in which the heart beats too slowly depriving the body of sufficient oxygen. MRI provides detailed images of organs and tissues without the use of radiation. While those images can help clinicians make informed decisions about treatment and care, most pacemakers are not compatible with MRI technology and therefore patients may not have access to the sophisticated scanning capabilities of the diagnostic system.
The ImageReady pacing system comprises the Boston Scientific Ingenio(TM) MRI pacemaker family and the new INGEVITY(TM) MRI pacing leads [pictured]. The proprietary technology is aimed at reducing MRI interference with device performance. The INGEVITY pacing lead platform is designed to provide key enhancements in handling and fixation, and is specifically engineered to function in the MRI environment.
"Physicians are very limited in device options and therapies labelled for use in the MRI setting," said Ronald Berger, M.D., Ph.D., professor of Medicine, Johns Hopkins Medical Institutions. "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 ImageReady pacing system is under clinical investigation and not currently available for sale in the United States.