Second Heart Assist announces the conclusion of its South American HRPCI Study with exemplary results

SALT LAKE CITY, Dec. 10, 2024 /PRNewswire/ -- Utah-based Second Heart Assist Inc., has completed the third in a planned series of studies at a leading clinical site in Asuncion, Paraguay, for use of mechanical circulatory support (MCS) for patients undergoing high-risk percutaneous coronary intervention (HRPCI). The findings indicate that its Whisper™ device, has again demonstrated excellent safety and efficacy for this indication.

The Whisper™ device continues to emerge as a superior candidate and contending technology for indications including HRPCI, acute decompensated heart failure (ADHF), and cardiogenic shock (CS), positioning it as the only truly percutaneous/minimally invasive 'all in one' solution.

The comprehensive trial program included 20 patients undergoing PCI and provided robust evidence demonstrating a significant increase in systemic blood flow generated by the pump, and its positioning in the abdominal aorta in close proximity to the kidneys which provides a significant increase in systemic and renal blood flow.  This supports our claims of superior improvement over competitors with true augmentation of native cardiac output.  This increase in renal perfusion helps combat the toxic effects of contrast dye used in diagnostic catheterizations and subsequent HRPCI procedures. Notably, the average increase in urine output — a primary end point of this research — exceeded that of rival devices and with rapid results during the PCI procedures ranging from 4 to 10 times greater diuresis over baseline.

Dr. Adrian Ebner commented on the performance of the Whisper™ device, noting, "The perfusion efficiency exhibited in these cases is remarkable. The simplicity is even more impressive with how safe, easy, and quick it is to utilize the device."

During the study, both deployment and removal times of the Whisper™ device were carefully recorded. On average, deployment took less than 60 seconds after arterial access was obtained, and removal took less than 30 seconds making it the easiest MCS support device in the field to use. Dr. Ebner's experienced team, conducting an average of four multi-vessel PCI procedures daily, handled the device with exceptional proficiency.

Alex Richardson, CTO of Second Heart Assist, who was actively involved on-site for every case stated, "The ability for clinicians to safely, quickly, and proficiently utilize our device is as equally rewarding as the results on its performance and what our key opinion leaders and industry have been seeking."

All patients supported by the Whisper™ device, exhibited improvement in cardiac output and maintained stable hemodynamic function during support, experienced minimal levels of hemolysis, and very successful outcomes and no patient adverse events. These results underscore the superior and consistent safety and efficacy of the Whisper™ device.

Jeff Donofrio, CEO of Second Heart Assist, commented, "After 30 years in the field of heart failure devices, I can say without hesitation that Second Heart Assist is making continued great progress in advancing the role and benefit of our device in the field of mechanical circulatory support for PCI as well as advanced heart failure, moving the needle in the right direction. Whisper™ will be a welcome addition to the market offerings and because of its ease of use and distinct advantages over the competition that will provide a major advance and key to in-patient improvements globally. We expect Whisper™ will soon gain a significant portion of the market share."

Dr. Leslie Miller, CMO of Second Heart Assist, added, "The results from this study further and strengthen our expectations of providing patients and practitioners with optimal solutions to address both PCI and HF needs. There is a significant and growing unmet need in these fields, and we aim to meet the demanding requirements with a safer, non-surgical approach that outperforms current market offerings. The unique design of the device, providing both direct cardiac and renal protective effects truly speaks volumes about the ability for this device to better serve unmet needs in heart failure and kidney support."

About Second Heart Assist Inc. 

Second Heart Assist Inc. (www.secondheartinc.com) is developing a temporary mechanical circulatory support (MCS) system that utilizes a stent cage fitted with a motorized impeller to aid 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).

Caution: the Whisper™ device is not approved and not for sale in any geography.

For more information, Dr. Leslie Miller, CMO ([email protected]). For investor relations, please contact Jeff Donofrio, CEO ([email protected]).

SOURCE Second Heart Assist Inc.