Whisper, a catheter-based, minimally invasive device, utilizes 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).
“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,” said Jeff Donofrio, CEO of Second Heart Assist.
Donofrio expects Whisper to soon gain a significant portion of the market share.
More about the Second Heart Assist study
Salt Lake City–based Second Heart Assist said investigators in Asuncion, Paraguay, completed their study in patients undergoing HRPCI. Findings indicated that Whisper demonstrated “excellent safety and efficacy” for the indication, according to a news release.
The study included 20 patients undergoing PCI. It showed a significant increase in systemic blood flow generated by the pump and its positioning in the abdominal aorta in close proximity to the kidneys provided a significant increase in systemic and renal blood flow. The company said this supports its claim of superior improvement over competitors with true augmentation of native cardiac output.
On average, deployment of Whisper took less than 60 seconds after obtaining arterial access in the study. Removal took less than 30 seconds. Second Heart Assist says this makes it the easiest mechanical circulatory support device in the field to use.
All patients supported by Whisper demonstrated improvement in cardiac output and maintained stable hemodynamic function during support. They experienced minimal levels of hemolysis and successful outcomes with no adverse events.
“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,” said Dr. Leslie Miller, chief medical officer of Second Heart Assist. “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.”
