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., Bolch, C.M., Tuzun, E. et al. J. of Cardiovasc. Trans. Res. (2019) 12: 155. https://doi.org/10.1007/s12265-018-9854-5 

 

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

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

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

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

CorInnova, Inc.

JLABS @ TMC

2450 Holcombe Blvd. Suite J

Houston, Texas 77021

Phone: (346) 772-0345

Email: info@corinnova.com

© 2020 CorInnova. All Rights Reserved.

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