Medical device developers can often be limited in pre-clinical experimental testing of new products because of procedural complexities and safety concerns to the animal or patient. Though animal or human cadavers can be used for these types of studies thereby eliminating the need for safety precautions, the functional capabilities of the tissue can be lost. As a novel way to provide such functional device/tissue assessment, the Visible Heart® (VH®) Laboratory has developed reanimation methodologies1 that allow the four chambers of the heart to contract naturally ex vivo. Swine hearts are routinely reanimated using this methodology with a clear perfusate which allows for direct endoscopic visualization of functional cardiac anatomy and importantly the device/tissue interface. For the past two decades, these capabilities have been useful for testing early device prototypes and developing educational and procedural videos. More specifically, this approach provides the added convenience of manipulating catheters into the ex vivo prep and visually studying their behavior for validation experiments of new medical devices. Further, multimodal imaging comparative assessments using both 4D echocardiography and fluoroscopy have been routinely performed. Yet, as imaging modalities continue to develop and are utilized for device placements or post-procedure evaluations, we hope to expand VH® capabilities.

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