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The VP.S ENCORE™ device is designed to have a significant impact on patients awaiting lifesaving or life-altering transplant surgeries by extending the viability of organs outside the body, and by extending the time for transport compared to traditional ice cooler technology. The primary goal in developing the VP.S ENCORE™ device include the ability to expand the donor organ pool, optimizing matching of the donor organs, and to minimize rejection.
The initial target organ for use of the VP.S ENCORE™ device is the heart. Outcome data collected to demonstrate optimal performance of the VP.S ENCORE™ device in animal studies include:

  • Minimal or no edema after preservation

  • Evidence demonstrating switching from anaerobic metabolism to aerobic metabolism during preservation

  • Tissue biopsies that indicate significantly lower inflammatory and cellular death markers when compared to the standard of care

  • Significantly higher contractility than hearts preserved with the standard of care, as tested in vitro using an isolated heart Langendorff device.

    • Preclinical tests demonstrate excellent preservation using animal hearts and human hearts donated for research.
    TRANSPLANT DATA
    We have began testing the VP.S ENCORE™ at Texas Heart Institute using an ovine heart transplant model. We first preserved a heart in the standard of care for 4 hours and then transplanted it to another sheep and followed up for up to 6 hours. We then preserved a heart in the VP.S ENCORE™ device for about 4 hours and then transplanted it to another sheep and followed up for 6 hours. VP.S ENCORE™ preserved heart demonstrated lower duration on bypass, it also required less medications to keep the heart beating (calculated by an index of vasopressor support) to maintain mean arterial pressure. Additionally, the cooler preserved heart had to be paced (electrical shocks to help the heart continue to beat) during the entire 6-hour follow-up, compared to no pacing for the VP.S ENCORE™ preserved heart. 
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    Biopsy Biomarkers from VP.S ENCORE™ perfused hearts for 8 hours
    compared to Cold Static Storage preserved hearts for 4 hours.
    Significant reduction of major inflammatory markers in hearts perfused for 8 hours in VP. S ENCORE™ versus cold static storage hearts preserved for 4 hours indicates that ischemic damage is reduced in hearts preserved in VP.S ENCORE™
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    Lactate trend during perfusion
    Hearts preserved with VP.S ENCORE™ go from anaerobic metabolism (producing lactate) to aerobic metabolism (consuming lactate)
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    Left ventricular contractility using an isolated heart model.
    Hearts placed on an isolated heart model after perfusion and after static cold storage were compared. VP.S ENCORE™ preserved hearts for 4 hours had significantly higher contractility than standard of care preserved hearts for 4 hours. In addition, hearts preserved for 8 hours, extended mode, and 24 hours showed higher contractility than standard of care preserved hearts.
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    In addition to having a positive impact on the lives of patients awaiting transplants, the VP.S ENCORE™ device is designed to allow surgeons and surgical centers to better schedule and manage their procedures. Moreover, should more organs become available for transplant, surgeons will ideally be able to perform more lifesaving and life-transforming surgeries.