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New Clinical Data Presented at EuroPCR Demonstrates that TriGuard Reduces Brain Lesion Volume during TAVR
Date:5/22/2013

ion volume in DEFLECT-I was 17 x smaller than the average in the reported literature (0.39 vs. 6.45 cm3), representing a 94% reduction.
  • Maximum total lesion volume in DEFLECT-I was 95% smaller than the maximum total lesion volume in reported studies (3.94 vs. 70.3 cm3).
  • Average (mean) single lesion volume in DEFLECT-I was 65% smaller than the average of reported historical data (0.12 vs. 0.34 cm3), and average total lesion volume was 57% smaller than reported average total lesion volume in reported historical data (0.7 vs. 1.64 cm3).  
  • In addition, the brain protection by TriGuard™ was safe, with no device related adverse events, had no interference with TAVR procedure, and performed optimally covering all three cerebral branches in 87% of the cases throughout valve replacement.
    TriGuard™, the only embolic protection device designed to cover all aortic cerebral branches, is fashioned to accommodate various anatomical variations of the aortic arch.

    Keystone Heart's presence at EuroPCR, Europe's largest professional meeting specializing in interventional cardiovascular medicine, was greeted with great interest.  Focus on cardiovascular procedure related brain damage, clinically evident and silent stroke, and potential preventative measures was emphasized in additional sessions, as well as in non-affiliated scientific presentations throughout the course and congress.

    Keystone Heart's Scientific Advisory Board Meeting was held adjacent to EuroPCR.  Participating key opinion leaders reached unanimous agreement on a number of issues:

    • Stroke is a devastating adverse event after cardiovascular procedures
    • Systemic therapy is highly unlikely to prevent strokes related to dislodgement of calcified material and valve particles
    • Mechanical protection such as filte
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    SOURCE Keystone Heart
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