MRI Labeling For Boston Scientific's Emblem MRI S-ICD Approved By US FDA
Boston Scientific cardiac rhythm management has been struggling to compete with MRI-compatible devices from rival Medtronic.
You may also be interested in...
Device Debuts: BSX's Resonate ICD; SYK's Tritanium C Anterior Cervical Cage; ZBH's Persona Partial Knee; MDT's Concerto 3D Coil
This edition of Medtech Insight's Device Debuts includes Boston Scientific's US launch of the Resonate MRI-compatible ICDs, Stryker's Tritanium C 3D-printed anterior cervical cage, Zimmer Biomet's Persona partial knee, and Medtronic's Concerto 3D peripheral aneurysm coil.
HRS 2017: Medtronic And Boston Scientific's Less-Invasive CRM Devices Perform As Hoped In Real-World Registries
Results from the post-approval trials of Medtronic's Micra Transcatheter Pacing System and Boston Scientific's S-ICD presented at the Heart Rhythm Society Scientific Sessions in Chicago show these "leadless" devices can be implanted in "real world" patients with acute outcomes similar to those of the pre-market trials that had more restrictive inclusion criteria.
The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.