Second Heart Assist announced data from a study highlighting the performance of its Whisper device against a competitive heart pump. The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed Impella CP when both pumps were operated at their maximum speeds.
Second Heart Assist said its study utilized two identical in vitro blood circulatory loops. It compared the hemolytic effects of the devices under identical hemodynamic, temperature and all test conditions. The study adhered to standards defined by the FDA and set by the American Society for Testing and Materials.
According to a news release, the research involved testing five Whisper devices at 10,000 RPM. It compared Impella CP at approximately 44,133 RPM, necessary to match the flow rate of Whisper. Analysis used the tetramethylbenzidine method to measure plasma free hemoglobin, a key indicator of hemolysis.
Findings showed that Whisper had a lower change in plasma-free hemoglobin. Additionally, it “significantly outperformed” Impella CP in both the normalized index of hemolysis and the modified index of hemolysis.
Second Heart Assist said the study goes beyond Impella CP, with findings relative to all micro-axial pump designs.
“These results suggest that the Whisper device could potentially offer a far safer alternative in clinical settings where high rotational speeds are necessary, thereby reducing the risk associated with hemolysis,” Second Heart Assist said. “This may play a critical factor when selecting devices for therapeutic durations exceeding even just one hour before potential acute kidney injury (AKI) caused by high levels of hemolysis.”
Whisper, a catheter-based, minimally invasive device, utilises a stent cage fitted with a motorized impeller. It aids in providing circulatory support throughout a patient’s body.
The system is intended for use in patients hospitalized with acute decompensated heart failure (ADHF) and who develop diuretic resistance with persistent congestion (cardio-renal syndrome (CRS), and/or cardiogenic shock (CS), and those in need of prophylactic hemodynamic support during high-risk percutaneous coronary intervention (HRPCI).
