TMI is developing the POINT-GUARD, the first and only cerebral embolic protection device with dynamic Double-Edge Sealing. The seal adapts and conforms to complex arch anatomy by maintaining contact with the aorta, enabling maximum great arch vessel coverage, and directing debris-laden blood through the filter. Thus, safeguarding the brain to provide complete embolic protection for addressing the unmet clinical need to keep debris out of the cerebral arteries and protect all territories of the brain during left heart procedures. Initial procedure focus is Transcatheter Aortic Valve Replacement (TAVR). During TAVR, procedural stroke is documented as high as 9.1% and clinically-significant debris is present in 99% of patients (SENTINEL Trial, Control Arm Data, JACC, Nov 2016).

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