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Pre-Clinical Status

Fourteen successful preclinical studies at Cleveland Clinic¹ and Dartmouth Medical Center have demonstrated VentriFlo’s pulsatile flow, adequate perfusion of critical organs, and successful weaning in both 3 and 6 hour procedures using a porcine model.

Histological examinations indicated all organs were normal, and there was no evidence of acute ischemic change or thromboembolism.¹

In-vitro studies demonstrate low hemolysis.

¹ASAIO 62nd Annual Conference – poster presented by G. Sunagawa, et al. “New Technology to Achieve True Physiologic Pulsatile Flow during Cardiopulmonary Bypass.” (June 2016; San Francisco, CA)

Dr. Jack Copeland on VentriFlo's Technology

Benefits

Blood pump technology has evolved from constant continuous flow, to synthetic pulse. Imagine the positive impacts a true pulsatile blood pump could have…
Would it improve microcirculation?
~30% of capillary beds do not open during continuous flow extracorporeal circulatory support.

AmSECT/AATS Annual Conference 2017
(abstract: CBP Induced Acute Kidney Injury (AKI) Can Pulsatile Flow Mitigate the Risk?);
Ann Thorac Surg 2012 94(6):2046-53;
J Applied Physiol 2012 112(10) 1727-34;
Am J Physiol Regul Integr Comp Physiol. 2006 290(5):R1153-67;
ASAIO Journal 2005 51(1):30-6;
Artificial Organs 2002 26(11):919-23

Would it improve critical organ perfusion?
Both continuous and simulated pulsatile extracorporeal pumps are unable to deliver blood flow in the same manner as the native heart.

Artificial Organs 2015 39(1): E1-9;
ASAIO Journal 2005 51(5):600-3;
Ann Thorac Surg 1994 58:1199-204;
Perfusion 1988 3:251-62

VentriFlo achieves 84% vs. 36% optimal flow; and >2x capillary perfusion vs. current technology

ASAIO Annual Conference 2017 Poster 103
(abstract: Impact of Physiologic Pulsatile Flow on Microcirculation During Cardiopulmonary Bypass)

Would it decrease complication rates?
30-50% of extracorporeal circulatory support patients suffer complications related to inadequate perfusion.

STS Congenital Heart Surgery Database 2015 Harvest – Children, Infants and Neonates Executive Summary;
Perioperative Kidney Injury 2015, Chapter 8;
Pediatric Crit Care Med. 2014 15(3): e111–e119

Would it help shorten hospital stays?
A comparison of continuous and simulated pulsatile flow during CPB indicates a ~40% reduction in both ICU stays and hospital stays for pediatric patients when using simulated pulsatile flow

Artificial Organs 2013 37(1):82-6

Would it help improve patient outcomes?
40-60% of patients undergoing VA-ECMO do not survive. Further, just 1-2 days of transient AKI negatively impacts survival 5 years later.

ELSO Jan 2016 report;
ASAIO Journal 2015 61(1):2-7;
Artificial Organs 2015 39(11):926-30;
Ann Thorac Surg 2010 90(4)1142-8

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