ImpediMed Announces First Patient Enrolled at Scripps Memorial Hospital in 200-Patient Heart Failure Trial
16 October 2018 - 12:00AM
Business Wire
ImpediMed Limited (ASX: IPD), a global provider of medical
technology to non-invasively measure, monitor and manage tissue
composition and fluid status using bioimpedance spectroscopy (BIS),
announces that the first patient has been enrolled in its
200-patient Heart Failure (HF) trial now being conducted at Scripps
Memorial Hospital, San Diego, CA.
With the first patient in this at-home HF trial now enrolled,
the study will follow patients at-home for 45 days post discharge
from a HF-related hospital admission. The study is designed to
demonstrate the extent to which changes in SOZO® BIS measurements
preempt patient-reported symptoms of HF that lead to hospital
readmissions. Data has shown 25 percent of patients admitted for HF
will be readmitted in <30 days. Earlier identification of fluid
overload allows for treatment changes which have resulted in
significant reduction of costly re-hospitalization.
A.J. Accardi, M.D. from Scripps Memorial Hospital in San Diego
states, “We are very excited about enrolling the first patient in
this new 200-patient trial with ImpediMed. SOZO has the potential
to significantly improve the quality of life for heart failure
patients by enabling them to remotely monitor their fluid status so
that clinical intervention can take place as soon as possible. This
early intervention is critical to helping prevent the occurrence of
rehospitalization.”
HF is the most common discharge diagnosis among patients age 65+
and the primary cause of readmission within 60 days. Management of
HF currently costs the U.S. healthcare system approximately $31
billion in hospitalization costs alone, and the overall global
economic toll in 2012 was estimated at $108 billion annually.
Richard Carreon, managing director and CEO of ImpediMed says,
“We are very pleased to have begun enrollment in this clinical
trial, which will further build on the data already being generated
in various independent trials of SOZO in heart failure. We believe
SOZO’s ability to accurately and noninvasively measure and monitor
small fluid changes in the human body has the potential to greatly
improve these patients’ lives while also providing tremendous
savings to the healthcare system.”
SOZO has already received US FDA clearance and a CE Mark for use
in heart failure patient monitoring. The data being generated from
these trials will support future marketing efforts.
About ImpediMed
Founded and headquartered in Brisbane, Australia, with U.S. and
European operations, ImpediMed is the world leader in the design
and manufacture of medical devices employing bioimpedance
spectroscopy (BIS) technologies for use in the non-invasive
clinical assessment and monitoring of tissue composition and fluid
status. ImpediMed produces a family of FDA cleared and CE Marked
medical devices, including SOZO® for multiple indications,
including heart failure and lymphedema, sold in select markets
globally. Visit www.impedimed.com.
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Media:Laura Carabello, 201.641.1911
x12lcarabello@cpronline.com
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