SALT LAKE CITY, July 25, 2024 /PRNewswire/ — Utah-based Second Heart Assist Inc., announced today the successful completion of the company’s first Central American case to evaluate the performance of its Whisper™ percutaneous mechanical circulatory device. The device is designed to improve both cardiac function and renal perfusion in patients hospitalized with acute decompensated heart failure (ADHF). Second Heart Assist has already performed FIH studies in Panama (South America) and other OUS countries for multiple indications.
Second Heart Assist team at Punta Pacifica Hospital, Panama led by Dr. T. Diaz, Alex Richardson, Dr. S. Joseph.
A resident of Panama developed severe cardiomyopathy and progressive biventricular heart failure following a COVID infection. The patient was hospitalized multiple times in the months prior to admission, presenting with severe volume overload and cardiogenic shock as confirmed by hemodynamic monitoring (“terminal heart failure” as stated by the patient’s physician). Initial treatment included IV diuretics, but with only modest success. Hemodynamic monitoring confirmed cardiogenic shock with an initial cardiac index of 1.4 liters/min (normal is 2.4 liters/min) and elevated left and right heart filling pressures.
The Second Heart Assist Whisper™ device was quickly inserted and resulted in an immediate increase in urine output, which persisted for 25 hours during the device’s flawless performance. Hemodynamics returned to near normal within 24 hours. The patient was discharged less than 48 hours after receiving therapy and only 5 days after presenting with cardiogenic shock.
Dr. Leslie Miller, Chief Medical Officer of Second Heart Assist Inc., said, “I am immensely pleased with the outcomes of the recent case involving our device. The pump performed flawlessly, delivering significant and rapid improvements in hemodynamic parameters through high-volume diuresis. I am optimistic about the transformative potential of our device in treating heart failure.”
This case demonstrates the power and safety of early initiation of the SHA device in the management of advanced heart failure, particularly in patients with severe volume overload and diuretic resistance.
About Second Heart Assist Inc.
Second Heart Assist Inc. is developing a temporary mechanical circulatory support (MCS) system. The system is designed to provide circulatory support for patients hospitalized with acute decompensated heart failure (ADHF) who develop diuretic resistance, persistent congestion, cardio-renal syndrome (CRS), cardiogenic shock (CS), or those requiring support during high-risk percutaneous coronary intervention (PCI).
Disclaimer: The Whisper™ device is not approved and is not for sale in any geography.
For more information, please contact:
Jeff Donofrio, CEO (jdonofrio@secondheartinc.com)
Dr. Leslie Miller, CMO (lmiller@secondheartinc.com)