In an effort to give patients with pacemakers fuller access to sophisticated diagnostic equipment, Boston Scientific (NYSE: BSX ) will evaluate whether it's safe to give patients with its new pacing system MRI scans.
According to the company, most pacemakers are not compatible with magnetic resonance imaging systems because MRIs create interference with the performance of pacing systems, which are designed to treat bradycardia, a condition in which the heart beats too slowly and deprives the body of sufficient oxygen. Thus patients end up being unable to access the technology's full scanning capabilities.
As a result, Boston Scientific says it will test its next-generation ImageReady MR Conditional pacing system in the SAMURAI clinical trial, which is designed to confirm the safety and effectiveness of the system in an MRI environment.
The ImageReady pacing system is under clinical investigation and not currently available for sale in the United States. The SAMURAI trial is a two-group randomized global clinical study designed to support FDA regulatory approval and is expected to enroll approximately 363 patients at 45 centers in seven countries.