Whisper Device Outperforms Impella CP in Recent Study
The recent findings demonstrate that the Whisper™ device by Second Heart Assist Inc. offers significantly lower hemolysis compared to the well-known Impella CP device. This pivotal study utilized sophisticated testing methods, as established by the FDA and the American Society for Testing and Materials, to evaluate the performance of these medical devices under controlled conditions.
Details of the Study Conducted
This comprehensive research took place at the Texas Heart Institute, which tested the effectiveness of five Whisper™ devices against a comparable Impella CP device. The Whisper™ device was assessed at a speed of 10,000 RPM, while the Impella CP was tested at a much higher speed of approximately 44,133 RPM to match the Whisper's output. The Whisper™ typically operates at lower speeds of around 7,000 to 7,500 RPM, maintaining the essential pulsatility of the heart while also ensuring adequate blood flow.
Key Findings on Hemolysis
The analysis utilized the tetramethylbenzidine method to assess plasma free hemoglobin levels, a crucial metric for understanding hemolysis. Results showed that the Whisper™ device exhibited not only a stunning reduction in plasma free hemoglobin but also excelled in both normalized and modified index of hemolysis measures when compared to the Impella CP.
Clinical Implications of the Whisper Device
The implications of these remarkable results suggest that the Whisper™ device could provide a safer option in clinical scenarios where high performance is critical. This is particularly relevant for procedures where the support duration exceeds one hour, as excessive hemolysis can lead to severe complications like acute kidney injury (AKI).
Advanced Design of the Whisper™ Device
Besides its proven efficiency, the study highlights that the design of the Whisper™ device addresses significant areas of concern associated with other 'micro-axial' pumps. These pumps often deal with complications stemming from their geometric configurations and high shear rates that can lead to hemolysis. The research illustrates that the Whisper's advanced technology outshines prior designs, positioning it as a potential leader in the market for mechanical circulatory support devices.
About Second Heart Assist Inc.
Second Heart Assist Inc. is spearheading the development of an innovative temporary percutaneous mechanical circulatory support (MCS) system that features a motorized impeller within a stent cage. This device aims to assist patients suffering from acute decompensated heart failure (ADHF) and improve outcomes for those facing diuretic resistance, persistent congestion, and cardiogenic shock.
The Future of Circulatory Support
It is important to note that while the Whisper™ device shows immense potential, it is still in the development phase and is not yet available for clinical use or sale. This focus on advancement highlights Second Heart Assist's commitment to improving the safety and effectiveness of circulatory support technologies.
Frequently Asked Questions
What is the Whisper™ device?
The Whisper™ device is a next-generation percutaneous mechanical circulatory support system designed to aid patients with severe heart failure.
How does the Whisper™ device compare to Impella CP?
The Whisper™ device has been shown to cause significantly less hemolysis compared to Impella CP, making it a safer alternative in clinical settings.
What were the findings of the recent study?
The study found that the Whisper™ device had a lower change in plasma free hemoglobin and significantly better hemolysis indices than Impella CP.
What are the clinical implications of these findings?
The findings suggest that the Whisper™ device may reduce risks associated with hemolysis, particularly in prolonged therapeutic scenarios.
When will the Whisper™ device be available?
The Whisper™ device is currently in development and is not yet available for use or sale in any market.
