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, designed to improve
both cardiac function and renal perfusion in patients hospitalized
with acute decompensated heart failure (ADHF). Second Heart Assist
has already successfully performed FIH studies in Panama (South
America) and other OUS countries for multiple
indications.
A resident of Panama developed
severe cardiomyopathy and progressive biventricular heart failure
following a Covid infection several years earlier that led to
multiple hospitalizations and three in past several months prior to
the admission where the patient presented severe volume overload
and cardiogenic shock as confirmed by hemodynamic monitoring
("terminal heart failure" as stated by the patient's
physician). Like previous admissions, initial treatment included
another course of high dose IV diuretics for two days, with only
modest success. Per protocol, hemodynamic monitoring was initiated
that confirmed the cardiogenic shock with an initial cardiac index
of 1.4 liters/min, (normal 2.4 liters/min), and very elevated left
and right heart filling pressures that were both greater than 3
times the normal values. The Second Heart Assist Whisper™
device was easily and quickly inserted and was associated with an
immediate and very large increase in urine output (over 400% over
the previous hour) that persisted throughout the 25 hours of
flawless device performance before planned and uneventful device
removal. Despite the very significant diuresis during device use,
there was an actual improvement in measured renal function
(Creatinine) that persisted even after device removal. Hemodynamics
returned to near normal within 24 hours and the patient was then
converted to oral heart failure medications and discharged less
than 48 hours after receiving therapy from the Whisper™ device, and
only 5 days after the presentation in cardiogenic shock.
"I am immensely pleased with the outcomes of the recent case
involving our device. Both the implantation and explantation
processes were seamless and successful. The pump performed
flawlessly, delivering significant and rapid improvements in
hemodynamic parameters through high-volume diuresis. I am thrilled
by the progress we are making at Second Heart Assist and am
optimistic about the transformative potential of our device in
treating heart failure," said Dr. Leslie
Miller, Chief Medical Officer of Second Heart Assist
Inc.
This patient demonstrates both the power and safety of early
initiation of the SHA device in the management of patients with
advanced heart failure who present with severe volume overload that
develop diuretic resistance and have persisting congestion.
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 (PCI).
Caution: the Whisper™ device is not approved and not for sale in
any geography.
For more information, please contact Jeff Donofrio, CEO
(jdonofrio@secondheartinc.com) or Dr. Leslie Miller, CMO
(lmiller@secondheartinc.com).
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SOURCE Second Heart Assist Inc.