Second Heart Assist recently announced the successful conclusion of the third planned evaluation phase for its innovative mechanical circulatory support device. Designed as a catheter-based, minimally invasive tool, the Whisper system functions with a stent cage containing a motorized impeller to assist in blood circulation throughout the body. This device targets patients dealing with acute decompensated heart failure (ADHF) who experience diuretic resistance and persistent congestion (as seen in cardio-renal syndrome (CRS) or cardiogenic shock (CS)), and those needing prophylactic hemodynamic support amid high-risk percutaneous coronary interventions (HRPCI).
According to Jeff Donofrio, CEO of Second Heart Assist, “With over three decades dedicated to heart failure devices, I confidently assert that Second Heart Assist is significantly advancing the benefits and applications for mechanical circulatory support devices within both PCI and severe heart failure sectors. The Whisper device is poised to be a prominent market solution due to its usability and superior competitive edge, heralding global in-patient improvements. We are optimistic Whisper™ will capture a considerable market share shortly.”
Insights into the Second Heart Assist Research
Headquartered in Salt Lake City, Second Heart Assist highlighted that researchers based in Asuncion, Paraguay, finalized their examination with HRPCI patients. Results indicated “remarkable safety and effective performance” for the intended application.
Involving 20 participants undergoing PCI, the study revealed notable enhancement in systemic blood flow driven by the pump. Its strategic placement near the abdominal aorta, adjacent to the kidneys, delivered a noteworthy rise in systemic as well as renal circulation. This finding supports the company’s assertion of superior enhancement compared to competitors by authentically boosting native cardiac output.
On average, the Whisper device’s setup required less than 60 seconds post-arterial access, and removal was completed in under 30 seconds. Second Heart Assist maintains this makes the Whisper the simplest mechanical circulatory support device available.
Every patient assisted by Whisper exhibited improvements in cardiac performance, stable hemodynamic conditions during use, minimal hemolysis, and no adverse events.
Dr. Leslie Miller, the chief medical officer at Second Heart Assist, noted, “The study’s results solidify our belief in providing ideal solutions for PCI and HF challenges. With a mounting unmet demand in these areas, our goal is to deliver a non-surgical, safer approach surpassing current solutions. Whisper’s unique capability to offer direct cardiac and renal protection underscores its potential to address gaps in heart failure and kidney support needs.”