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The Breakthrough in Mechanical Circulatory Support: SHA Whisper Device

In an era where advancements in medical technology are pivotal for improving patient outcomes, the Second Heart Assist Inc. has made a significant breakthrough with its Whisper™ device. A recently published study found that this next-generation percutaneous mechanical circulatory support (pMCS) system notably reduces hemolysis—a critical factor affecting patient safety. The findings were unveiled at the Texas Heart Institute (THI) and were rigorously tested against the popular Impella CP® device.

Understanding Hemolysis and Its Impact

Hemolysis refers to the breakdown of red blood cells, which can occur when blood is subjected to mechanical stress during circulation. High levels of hemolysis can lead to a range of complications, including acute kidney injury (AKI) and other serious health issues. Clinical environments often necessitate high pump speeds to maintain adequate blood flow, which can inadvertently increase hemolysis rates.

The Study – Methodology and Findings

The study involved a controlled comparison between the Whisper™ device operating at 10,000 RPM and the Impella CP®, which was tested at approximately 44,133 RPM to achieve matching flow rates. According to the FDA guidelines, the Whisper™ typically operates between 7,000 to 7,500 RPM under normal conditions, thus maintaining natural blood flow dynamics.

Utilizing a sophisticated analysis method known as the tetramethylbenzidine method, researchers measured plasma free hemoglobin levels, a reliable marker for assessing hemolysis. The results illustrated that the Whisper™ significantly surpassed the Impella CP® not only in terms of lower changes in plasma free hemoglobin levels but also in both normalized and modified indices of hemolysis.

Clinical Implications and Future Prospects

The findings indicate that the Whisper™ is primed to be a safer alternative in clinical settings where prolonged use of high rotational speeds is required. This is particularly critical as high hemolysis levels can lead to adverse patient outcomes, especially when the therapeutic durations exceed an hour.

The Whisper™ device’s capability to achieve flow rates up to 6.8 liters per minute, while maintaining native flow and heart pulsatility, sets it apart from other devices that rely on non-pulsatile flow. Such advancements underscore the importance of design and operational efficacy in mechanical circulatory support systems.

The relevance of this study extends beyond active comparisons to the Impella CP®; it sets a benchmark for other micro-axial pump designs. The implications of these findings resonate in the fields of cardiology and emergency medicine, providing a lens through which future designs and improvements can be evaluated.

About Second Heart Assist Inc.

Second Heart Assist Inc. is dedicated to developing innovative pMCS technologies designed to assist patients suffering from acute decompensated heart failure (ADHF), cardio-renal syndrome (CRS), and those in critical need of hemodynamic support during high-risk procedures. The Whisper™ device, although not yet available for commercial use, promises a new frontier in mechanical circulatory support for patients at risk.

For more information about the findings of this study and the Whisper™ device, visit the Second Heart Assist Website. Should you have inquiries regarding investor relations or specific information requests, feel free to reach out to the company’s representatives mentioned in the article.