Shots:
- FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year
- Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral Protection System, meeting its primary safety & clinical performance endpoints, showing Emboliner captured significantly more debris during TAVR
- Emboliner provides comprehensive cerebral & systemic embolic protection during TAVR by capturing & removing debris before it reaches vital organs. Its circumferential dual-layer filter protects cerebral & systemic circulation while allowing the TAVR delivery system through its central lumen
Ref: PRnewswire | Image: Emboline | Press Release
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