Preclinical readiness testing of the arrow international CorAide left ventricular assist system

Axial and centrifugal continuous-flow rotary pumps: A translation from pump mechanics to clinical practice

“…The average PI HM II for the axial HeartMate II bridge-to-transplantation (BTT) trial was 5.0 Ϯ 0.9, and the average PI calculated as PI HM II for the centrifugal CorAide European clinical trial was 12.1 Ϯ 2.6, demonstrating more than twice the flow pulsatility. 3,18,19 Although flow pulsatility data for the HeartWare HVAD clinical trial are not available, it is recommended to maintain a minimum of 2 to 4 liters/min for pump flow operating ranges of 3.5 to 7.0 liters/min, which equates to a PI HM II value of 5.7.…”

“…The CorAide centrifugal LVAD used sensorless flow estimates, high pump flow pulsatility response to changes in the status of the LV, and much lower LV suction levels during transient periods of low LV volume to successfully implement a physiologic automatic pump control algorithm in its European clinical trial. 19,21 In this limited trial of 21 patients, 72% of the total trial implant duration (16.6 patient-years) was run in automatic mode (personal unpublished data).…”

“…It is typically displayed as some form of the ratio of the peak flow during systole (flow max ) or the total swing in flow during a cardiac cycle (flow max -flow min ) over the average pump flow (flow avg ). 3,18,19 , This is normally derived by averaging the recorded instantaneous peak flows or flow swings over each cardiac cycle for approximately 10 to 15 seconds and then calculating the average total pump flow over that same period. The formula for calculating a PI for the HeartMate II (PI HM II ) 20 For example, if rotary pump flow values for flow max , flow min , , and flow avg were 8, 4, and 6 liters/min, respectively, the PI HM II would be 6.7.…”

Initial In Vivo Evaluation of the DexAide Right Ventricular Assist Device

“…3 We developed the CorAide LVD-4000 Assist System (Arrow International, Reading, PA), an implantable, third-generation, centrifugal pump as an LVAD. [5][6][7][8][9] The rotating assembly, the only moving part, is fully suspended without mechanical contact or wear during operation. The CorAide blood pump demonstrated excellent biocompatibility and reliable, effective system performance in a series of 24 long-term in vivo experiments that included 12 experiments without any anticoagulation therapy, [7][8][9] and an initial clinical study was initiated.…”

Sistema de controle para diagnóstico e tratamento de falhas em dispositivos de assistência ventricular.

“…Essas falhas são discutidas amplamente na literatura (CAMP SORRELI, 2007;HILL;REINHARTZ, 2006;PARK et al 2009;LEGENDRE, 2009;ISO, 2007;YI, 2007 (WHITE, 2009;BOLLING, 2011;MORELLO, 2011;BEN SHALOM, 2011a;ROBERT, 2009;FRAZIE et al, 2004;BEN SHALOM, 2011b;SCHMIDT et al, 2003;MURAMATSU;MASUOKA;FUJISAWA, 2001;SNYDER, TSUKUI et al, 2007;DOI et al, 2004;EL BANAYOSY et al, 2006;FRENCH; ANDREAS; GIFFORD III, 2006;CHEN et al, 2002;COTTER;BATAILLE, 2010;LOREE et al, 2001;LOCKE et al, 2003;GEERTSMA et al, 2007;HILL;REINHARTZ, 2006;COLEMAN;COLEMAN;COLEMAN;NEILL, 2006;DOWLING et al, 2004;PACELLA et al, 2004 • O material envolvido;…”