Interventional technology developer Boston Scientific announced it has implanted its ImageReady MR-conditional pacing system in the first patient enrolled in the ImageReady MR Conditional Pacing System Clinical Study (SAMURAI) at Ohio Health's Riverside Methodist Hospital in Columbus.
The trial is a prospective randomized multicenter clinical study designed to support an application for U.S. Food and Drug Administration (FDA) clearance. The trial is expected to enroll approximately 363 patients at 45 centers in seven countries.
The clinical study is designed to confirm the safety and effectiveness of the ImageReady system when a patient undergoes an MRI exam. The pacing system is designed to treat bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen.
The pacing system being tested in the SAMURAI clinical trial incorporates Boston Scientific Ingenio's MRI pacemakers and Ingevity MRI pacing leads. The company's proprietary technology is aimed at reducing MRI interference with device performance.
