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Preclinical Results

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Bench testing and acute/chronic animal studies have been implemented to support the first-in-human study. Large animal studies in an ovine acute heart failure model and in a chronic heart failure model demonstrate that the CorInnova device:

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  1. Is deployed minimally invasively through a small tube via a sub-xiphoid incision in a sheep (equivalent to a mini-thoracotomy through left ribcage in human)

  2. Stays on the heart via intrinsic pneumatic attachment and does not need to be sutured to the heart or aorta​

  3. Exhibits non-obligatory operation (when not being operated, does not significantly inhibit heart function), thereby permitting the user to turn the device on and off safely; note that LVAD operation is obligatory, lest thrombosis and stroke follow re-starting device

  4. Increases cardiac output during heart failure by on average 50% or more, and increases stroke work while reducing the percent of work done by the heart – demonstrating unloading

  5. Improves diastolic function by enhancing filling by increasing end diastolic volume and increasing total stroke volume

  6. Maintains natural curvature of the heart while operating, promoting normal heart motion

  7. Is easily removed as demonstrated by a 5-day safety pilot study

See published work for more detailed information about CorInnova's technology:

 

 

Hord E. C., Hager, M.P., Bolch, C.M., Bonugli, K., Guo, L., E. Tuzun, and J. C. Criscione. Preclinical Proof-of-Concept of a Minimally Invasive Direct Cardiac Compression Device for Pediatric Heart Support. Cardiovascular Engineering and Technology, November 21, 2023.

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G. V. Letsou, B. Leschinsky, W. Altman, C. Bolch, E. Hord, J. C. Criscione. A New Implantable Direct Cardiac Compression Device Improves Cardiac Performance in a Chronic Ovine Heart Failure Model. ISHLT 43rd Annual Meeting & Scientific Sessions, 2023.

 

G. Letsou, B. Leschinsky, W. Altman, C. Bolch, E. Hord, J. C. Criscione. Implantable Direct Cardiac Compression Devices Do Not Cause Cardiac Injury or Induce Thrombus Formation. ISHLT 43rd Annual Meeting & Scientific Sessions, 2023.

 

G. Letsou, E. Hord, W. Muir, B. Youngblood, W. Altman, B. Leschinsky, J.C. Criscione, C. Bolch. 14-day End-Organ Safety and Hemocompatibility with the CorInnova Direct Cardiac Compression Device in an Ovine Chronic Heart Failure Model. CRF 2nd Annual Technology and Heart Failure Therapeutics Meeting, 2023.

 

Letsou G. V., C. M. Bolch, E. C. Hord, W. C. Altman, B. L. Youngblood, B. Leschinsky and J. C. Criscione. Mechanical Cardiac Support With an Implantable Direct Cardiac Compression Device: Proof of Concept. The Annals of Thoracic Surgery 2022.

 

Letsou G. V., C. M. Bolch, E. C. Hord, W. C. Altman, B. Leschinsky and J. C. Criscione. The CorInnova Implantable Cardiac Assist System for Direct Cardiac Compression. RCM 23: 2022.

 

Letsou G. V., B. Leschinsky, E. Hord, C. Bolch and J. Criscione. Effective Diastolic Mechanical Support Using a New Implantable Cardiac Compression Device. The Journal of Heart and Lung Transplantation 40: S103-S104, 2021.

 

Letsou G. V., C. Bolch, E. Hord, B. Leschinsky and J. Criscione. Extracardiac Mechanical Support Device Placement by a Minimally Invasive Approach is Safe and Effective. The Journal of Heart and Lung Transplantation 39: S189-S190, 2020.

 

Hord E. C., C. M. Bolch, E. Tuzun, W. E. Cohn, B. Leschinsky and J. C. Criscione. Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model. Journal of Cardiovascular Translational Research 12: 155-163, 2019.

 

Criscione, J. Cardiovascular devices: Soft hugs for healing hearts. Nat Biomed Eng 1, 0046 (2017) doi:10.1038/s41551-017-0046 https://doi.org/10.1038/s41551-017-0046

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Snowden, T., Biswas, S., and Criscione, J. (July 5, 2013). "Modulation of Diastolic Filling Using an Epicardial Diastolic Recoil Device." ASME. J. Med. Devices. September 2013; 7(3): 034503. https://doi.org/10.1115/1.4024156

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Moreno, M. R., Biswas, S., Harrison, L. D., Pernelle, G., Miller, M. W., Fossum, T. W., Nelson, D. A., and Criscione, J. C. (November 28, 2011). "Development of a Non-Blood Contacting Cardiac Assist and Support Device: An In Vivo Proof of Concept Study." ASME. J. Med. Devices. December 2011; 5(4): 041007. https://doi.org/10.1115/1.4005281

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Moreno, M. R., Biswas, S., Harrison, L. D., Pernelle, G., Miller, M. W., Fossum, T. W., Nelson, D. A., and Criscione, J. C. (November 28, 2011). "Assessment of Minimally Invasive Device That Provides Simultaneous Adjustable Cardiac Support and Active Synchronous Assist in an Acute Heart Failure Model." ASME. J. Med. Devices. December 2011; 5(4): 041008. https://doi.org/10.1115/1.4004652

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