In a US FDA-mandated comparative study against a US-approved device, Second Heart Assist Inc. (SHA) validated its Whisper device’s ability to demonstrate significantly lower hemolysis compared to the only approved device on the market today, Johnson & Johnson / Abiomed Impella. This compelling published scientific study met identical testing conditions under strictly controlled standards, resulting in Whisper exhibiting approximately 50% less of the generated mechanical hemolysis than Impella. This reduction is attributed to shear, RPM, and other design factors.
Notably, Whisper requires a fraction of the required RPMs to generate the high levels of flow necessary for adequate renal perfusion, whereas Impella necessitates 6-7 times higher RPMs to achieve similar flow performance. Whisper typically operates at 7,500 RPM, while Impella must operate at over 44,000 RPM to achieve comparable flow requirements.
This data holds immense significance in the decisions regarding safe device selection, considering patient kidney condition and the duration of therapy. The generated hemolysis is a direct and primary contributor to toxic damage of compromised red blood cells in the kidneys, leading to Acute Kidney Injury (AKI) in nearly one-third of patients undergoing mechanical circulatory support device therapy for Acute Decompensated Heart Failure (ADHF), Angioplasty / High-Risk Percutaneous Intervention (HRPCI), and Cardiogenic Shock (CS). AKI often results in permanent damage and necessitates lifelong dialysis for patients.