Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its ImageReady MR-conditional pacing system.
The ImageReady system is intended to treat bradycardia, a condition in which the heart beats too slowly.
ImageReady system features Accolade magnetic resonance imaging (MRI) and Essentio MRI pacemakers, as well as the new Ingevity MRI pacing leads.
According to the company, patients implanted with the full system can receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.
The full ImageReady system and Ingevity MRI leads were approved based on data from two global clinical trials.
Ingevity trial assessed the safety, performance and effectiveness of the leads in 1,036 patients with a single or dual chamber pacemaker.
Samurai study assessed the safety and effectiveness of the ImageReady system in 351 patients with a single or dual chamber pacemaker.
ImageReady provides automatic daily monitoring through the Latitude Nxt patient management system.
Boston Scientific rhythm management chief medical officer Kenneth Stein said: "With a pacing system specifically designed with automatic remote monitoring that also allows patients to undergo MR scans, we are further advancing the quality of patient care.
"We believe that the daily monitoring capability of the ImageReady System, coupled with advanced diagnostics, will help physicians identify concerns and ultimately initiate patient care sooner."