New CHAMPION Data Show Significant Improvement in Survival Rates for Heart Failure Patients with Reduced Ejection Fraction
March 15 2015 - 11:21AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced a new data analysis from the CHAMPION
trial showing that heart failure (HF) patients with reduced
ejection fraction on optimal doses of guideline directed medical
therapy (GDMT) managed by pulmonary artery (PA) pressure monitoring
with the CardioMEMS™ HF System had a 57 percent reduction in
mortality and a 43 percent reduction in HF hospitalizations
compared with patients on GDMT managed by the standard of care
(SOC). These data show a strong improvement for patients managed by
optimal GDMT and the CardioMEMS HF System in both mortality and
hospitalizations over currently defined best practices.
The CardioMEMS HF System uses a
miniaturized, wireless monitoring sensor that is implanted in the
pulmonary artery. (Photo: Business Wire)
The analysis looked at patients with HF and reduced ejection
fraction (HFrEF) (when the heart muscle does not contract
effectively and less oxygen-rich blood is pumped out to the body)
over an average of 17 months who were on optimal GDMT and compared
those managed by PA pressure monitoring with the CardioMEMS HF
System to those managed by SOC. The CHAMPION trial retrospective
analysis demonstrated that PA pressure monitoring, in addition to
GDMT, significantly reduced HF hospitalizations and mortality in
patients with reduced ejection fraction.
This new retrospective data analysis entitled “Pulmonary Artery
Pressure Management in Heart Failure Patients with Reduced Ejection
Fraction Significantly Reduces Heart Failure Hospitalizations and
Mortality Above and Beyond Background Guide-Directed Medical
Therapy” was presented today during the American College of
Cardiology 64th Annual Scientific Sessions.
“For heart failure patients whose heart does not contract
effectively, the risk for hospitalization and mortality is very
high, even with appropriate evidence-based medical therapy. The
findings from this analysis show us that use of the CardioMEMS HF
System in addition to guideline directed medical therapy can
significantly reduce hospital admissions for these heart failure
patients and for the first time, we also see a significant
improvement in survival,” said Dr. William Abraham, chief of
cardiovascular medicine at The Ohio State University Wexner Medical
Center and presenter of these data.
The CardioMEMS HF System uses a miniaturized, wireless
monitoring sensor that is implanted in the pulmonary artery (the
artery that delivers blood from the heart to the lungs) during a
minimally invasive procedure to directly measure PA pressure.
Measuring PA pressure allows clinicians to proactively manage
treatment for patients with worsening HF before visible symptoms,
such as weight and blood pressure changes, occur. The system allows
patients to transmit PA pressure data from their homes to their
health care providers, who then manage appropriate medication
changes to reduce the likelihood of hospitalization and improve
survival.
“The positive data based on pulmonary artery pressure management
we see from the CHAMPION trial continue to demonstrate
groundbreaking ways our physician partners manage their heart
failure patients within the realities of the changing health care
landscape,” said Dr. Mark D. Carlson, chief medical officer for St.
Jude Medical. “St. Jude Medical is pioneering a new standard of
care for heart failure management and the CardioMEMS HF System is
the cornerstone of our heart failure portfolio.”
The CardioMEMS HF System is supported by strong clinical
evidence, including data from the CHAMPION (“CardioMEMS
Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in
NYHA Class III Patients”) trial published in The Lancet. The
CHAMPION trial evaluated the overall safety and effectiveness of
the CardioMEMS HF System for New York Heart
Association (NYHA) Class III HF patients who had been
hospitalized for HF in the previous 12 months. The CHAMPION trial
demonstrated a 37 percent reduction in HF hospitalizations during
an average follow-up duration of 15 months.
About Heart FailureThe Center for Disease Control
and Prevention reports that more than 5 million Americans
suffer from heart failure with 825,000 new cases diagnosed each
year. Roughly 1.4 million patients in the U.S. have NYHA Class III
HF, and historically these patients account for nearly half of all
HF hospitalizations. According to the American Heart
Association, the estimated direct and indirect cost of HF in the
U.S. for 2012 was $31 billion and that number is expected
to more than double by 2030.
Heart failure occurs when the heart is unable to pump enough
blood to meet the body’s demands and blood pressure within the
heart is elevated. Significant HF progression over a period of days
is known as acute decompensation and leads to hospitalization.
Increased PA pressures often precede indirect and non-specific
measures of worsening HF such as weight and blood pressure changes.
The CardioMEMS HF System, approved by the U.S. Food and
Drug Administration in May 2014, may allow clinicians to
stabilize PA pressures by proactively managing medications and
other treatment options while also providing an early indication of
worsening HF.
Learn more about the CardioMEMS HF System.
About St. Jude Medical’s Heart Failure
BusinessApproximately 26 million people worldwide suffer
from heart failure. St. Jude Medical is pioneering heart
failure disease management with innovative solutions like the
CardioMEMS HF System, market-leading, ground-breaking quadripolar
technology and, in select European markets, our first-to-market
MultiPoint pacing technology. St. Jude Medical collaborates
with heart failure specialists, clinicians and advocacy partners to
provide innovative, cost-effective solutions that help reduce
hospitalizations and improve patient quality of life for heart
failure patients around the world.
For more information about St. Jude Medical’s focus on heart
failure, visit the St. Jude Medical Heart Failure Media Kit.
About St. Jude MedicalSt. Jude Medical is a global
medical device manufacturer dedicated to transforming the treatment
of some of the world’s most expensive epidemic diseases. The
company does this by developing cost-effective medical technologies
that save and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more
information, please visit sjm.com or follow us on Twitter
@SJM_Media.
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SEC, including those described in the Risk Factors and Cautionary
Statements sections of the Company’s Annual Report on Form 10-K for
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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorKristi Warner, 651-756-2085Media
Relationskwarner@sjm.com
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