Business Highlights:
- Continued engagement with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application for the CGuard Prime carotid stent system in the U.S. Optimistic for an anticipated approval in the third quarter of 2025
- Advanced commercial infrastructure and operational readiness ahead of anticipated U.S. launch
- Continued enrollment with excellent pace in the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.