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Preclinical Validation

Preclinical & Validation Studies

Three porcine studies and two cadaver heart studies were completed at Brigham & Women’s Hospital, Boston. Evaluations were conducted with KOL interventional cardiologists and Coronary Scientific Advisory Board members.

Demonstrated outcomes include:

  • Safe access to left and right coronary arteries

  • High-resolution OCT visualization of arterial walls

  • ​Strong torque response, trackability, and deliverability.

  • Successful CTO negotiation in cadaver models.​

Clinical & Technical Advantages

Tigerheart™ aims to set a new benchmark in coronary CTO interventions enabling more predictable outcomes, safer procedures, and greater accessibility for patients worldwide.

Key highlights:

  • Ability to cross a mature, calcified CTO SynDaver model that leading competing microcatheters could not

  • Faster crossing and true-lumen engagement via directional tip control and real-time OCT guidance

  • Reduced procedure time by 50–75%

  • Robust biocompatibility: non-haemolytic, non-pyrogenic, non-irritant, and no systemic toxicity in GLP assays

  • Hemocompatibility: complement activation comparable to other competitive devices

  • Thrombogenicity in dog model: minimal thrombus with Tigerheart™ vs. minimal to severe with control

  • Particle generation after repeated crossing: in a SynDaver model study, no particles of size 150 microns or larger were generated by Tigerheart™; the largest observed particulate was 124 microns

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