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New FDA Clearance Protects TAVR Patients from Stroke
10 Sep
Summary
- Emboliner system received FDA 510(k) clearance for TAVR procedures.
- The device captures debris to protect cerebral and systemic circulation.
- Clinical study showed greater capture of clinically relevant debris.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Emboline's Emboliner embolic protection system. This innovative device is intended for use during transcatheter aortic valve replacement (TAVR) and similar cardiac procedures.
The Emboliner is designed to capture and remove embolic material, safeguarding both cerebral and systemic circulation. Its circumferential dual-layer filter aims to intercept debris generated during TAVR before it can reach vital organs like the brain and kidneys.
This clearance was based on the PROTECT H2H IDE study, a multi-centre trial that compared the Emboliner to the SENTINEL system. The study met its primary endpoints and showed the Emboliner captured significantly more clinically relevant debris. Emboline plans a phased US commercial launch later in 2026.
In March 2026, Emboline successfully raised $20 million to support the commercialization of its device, aimed at reducing stroke and ischemic damage in structural heart procedures.
