Data presented at HFSA 2014 showed PA pressure monitoring did not
adversely affect kidney function
Company Website:
http://www.sjm.com
ST. PAUL, Minn. -- (Business Wire)
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced a new data analysis from the CHAMPION clinical trial
that evaluated outcomes in a subgroup of patients with renal dysfunction
(kidney failure). The CHAMPION trial looked at the safety and
effectiveness of the CardioMEMS™
HF System for patients with New York Heart Association (NYHA) Class
III heart failure (HF) who had been hospitalized for HF in the previous
12 months.
The CardioMEMS system uses a miniaturized, wireless monitoring sensor
that is implanted in the pulmonary artery (PA) 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.
The subgroup data analysis of 297 patients followed for 18 months,
presented during the Heart
Failure Society of America (HFSA) 18th annual scientific meeting in
Las Vegas, looked at the potential benefit for patients with NYHA Class
III HF and chronic kidney disease (CKD) using the CardioMEMS system to
measure PA pressure without adversely affecting renal function. These
data show that management based on PA pressure reduced HF
hospitalization in this patient population by 42 percent compared to the
control group and did not adversely affect renal function.
“Patients who have heart failure often also suffer from chronic kidney
disease and the worry is that medical therapies to avoid hospitalization
will adversely affect renal function,” said Dr. William Abraham, chief
of cardiovascular medicine at The Ohio State University Wexner Medical
Center and primary investigator for the CHAMPION trial. “Our goal in
analyzing this group of patients was to demonstrate that monitoring
pulmonary artery pressure with the CardioMEMS HF System can reduce
hospitalizations without adversely affecting renal function and the data
shows this to be true.”
The Center
for Disease Control and Prevention reports that more than 5 million
Americans suffer from HF with 670,000 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.
“The CardioMEMS HF System is an innovative technology that helps
physicians proactively manage their heart failure patients without
adversely affecting the kidneys,” said Dr. Mark D. Carlson, chief
medical officer for St. Jude Medical. “This analysis and others
demonstrate our commitment to investing in clinical research that
provides physicians with data to improve patient care.”
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 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, allows
clinicians to stabilize PA pressures by proactively managing medications
and other treatment options while also providing an early indication of
worsening HF.
About St. Jude Medical
St. 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.
Forward-Looking Statements
This news release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties. Such
forward-looking statements include the expectations, plans and prospects
for the Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by
the Company are based upon management’s current expectations and are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. These risks and uncertainties include market conditions and
other factors beyond the Company’s control and the risk factors and
other cautionary statements described in the Company’s filings with the
SEC, including those described in the Risk Factors and Cautionary
Statements sections of the Company’s Annual Report on Form 10-K for the
fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q
for the fiscal quarter ended June 28, 2014. The Company does not intend
to update these statements and undertakes no duty to any person to
provide any such update under any circumstance.
Contacts:
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor
Relations
jweigelt@sjm.com
or
Kristi
Warner, 651-756-2085
Media Relations
kwarner@sjm.com
Source: St. Jude Medical, Inc.
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