Progress in the Development of the Pulsatile CorWave LVAD

Purpose The CorWave LVAD employs a unique “wave membrane” technology, inspired by the motion of aquatic animals, to generate blood flow. This low shear method of blood propulsion can be rapidly modulated to produce a physiologic pulse. CorWave LVADs have been implanted for up to 2 months in sheep with low hemolysis and good hemodynamic performance. We are finalizing the clinical system by confirming system durability, conducting final blood path optimization, and challenging the pump pulsatility control algorithms. Methods Computational simulations were used to optimize shear stress in the blood flow path to less than 9 dyn/cm2, the maximum that occurs in normal physiology. Test fixtures and prototype pumps were employed to confirm the hydraulic and hemocompatibility results with the optimized flow paths. Test pumps were placed in static and dynamic mock circulation loops for real-time testing, initially targeting 6 months, but then extending to indefinite test durations. The pulsatility control algorithms were tested for sensorless synchronization, arrhythmia detection, pulse pressure amplitude generation, in mock circulation loops (MCLs) and during acute implants in sheep with ischemia-induced heart failure. Results In vitro tests of the optimized flow paths confirmed significant improvements in hydraulic output and hemocompatibility measures. Hemolysis was reduced by 70%, while pump output increased by 30%. 7 pumps completed 6-month durability tests, with testing beyond 6 months ongoing in 6 additional pumps. The pulsatility algorithms successfully detected ventricular systole in heart failure models in MCLs and during acute implants, allowing the aortic valve to open with each beat prior to increasing the pump output. The algorithm identified arrhythmia conditions for safe transitions to non-synchronized operating modes. In vitro, CorWave pumps generated pulse pressures exceeding 30 mmHg, while in vivo pulse pressure increased to over 25 mmHg but was constrained due to limitations of the animal model. VWF multimers were preserved during the acute implants. Conclusion The CorWave LVAD has achieved milestones for durability, hemocompatibility, and pulsatile operation, demonstrating substantial progress towards clinical readiness.