Prospective data from the CHAMPION study shows that after 31
months of follow-up, heart failure patients managed with the
CardioMEMS HF System had a 48 percent reduction in heart failure
hospitalizations compared to patients managed with standard of
care.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the publication of new, prospective data
in The Lancet journal further supporting the long-term
effectiveness of the CardioMEMS™ HF System at reducing heart
failure (HF) hospitalizations for patients with New York Heart
Association (NYHA) Class III HF.
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The CardioMEMS HF System uses a
miniaturized, wireless monitoring sensor that is implanted in the
pulmonary artery. (Photo: Business Wire)
The analysis shows that after moving from standard HF therapy to
management based on information from the CardioMEMS HF System,
patients from the study’s control group had a 48 percent reduction
in HF hospitalizations.
The CardioMEMS HF System was approved by the Food and Drug
Administration (FDA) in May 2014 based on clinical data from the
landmark CHAMPION clinical study, which had an average follow-up
duration of 15 months. The new publication provides results over an
extended time period (an average of 31 months) demonstrating the
long-term benefit of hemodynamic monitoring in reducing heart
failure hospitalization in these high risk patients.
All patients were implanted with the CardioMEMS sensor at the
beginning of the study. The treatment group was monitored with the
CardioMEMS HF System throughout the study with an average of 31
months of follow up. For the first 18 months, doctors treating
patients in the control group were blind to the PA pressure
readings and did not take readings into account when determining
their treatment plan. Once physicians had access to the sensor
readings for patients in the control group (open access period),
they made patient management decisions based on pulmonary artery
(PA) pressure data received from the CardioMEMS sensor rather than
decisions based on signs and symptoms of worsening HF. This portion
of the study represented a “real-world” experience since, based on
the protocol, the study sponsor no longer provided communication
with the study centers.
“This rigorous analysis showed a dramatic long-term impact for
high-risk patients who were managed with the CardioMEMS HF System,”
said Dr. Philip B. Adamson, medical director and vice president of
medical affairs for St. Jude Medical. “During the first 18 months,
the control group hospitalization rates remained high but once
patient management using pressure data from the CardioMEMS HF
system was introduced for the first time, we saw a hospitalization
reduction of almost 50 percent, a clinically and highly
statistically significant result.”
“Despite advances in medical care, a significant number of heart
failure patients are readmitted to the hospital within a relatively
short period of time and every hospitalization is very traumatic
for those patients and their families,” said Dr. William Abraham,
chief of cardiovascular medicine at The Ohio State University
Wexner Medical Center. “The longitudinal analysis shows an
important reduction in these admission rates when patients are
monitored with the CardioMEMS HF System.”
Upon the treating physicians having access to the CardioMEMS PA
pressure readings and managing the control group patients based on
pressures, patients in the control group of the study experienced a
statistically significant 48 percent reduction in HF
hospitalizations. In addition, hospitalization rates continued to
remain low in the treatment group during the open access period
demonstrating the durability of the effect of home hemodynamic
monitoring.
The CHAMPION study originally demonstrated a statistically and
clinically significant 28 percent reduction in the rate of HF
hospitalizations at six months, and a 37 percent reduction in HF
hospitalizations during an average follow-up duration of 15 months.
This new long-term, prospective data further supports the
effectiveness of the CardioMEMS system at reducing HF
hospitalizations by demonstrating the system can provide physicians
the opportunity to proactively manage their HF patients.
The CardioMEMS HF System uses a miniature wireless monitoring
sensor implanted in the PA to directly measure blood pressure and
heart rate data. Patients can transmit this data from home to their
health care providers, allowing providers to stabilize PA pressure
by managing the patient’s medications more effectively.
The CardioMEMS HF System is the first and only FDA-approved HF
monitor that, when used by physicians to monitor their HF patients,
has been shown to significantly reduce HF hospital admissions and
improve the quality of life in NYHA Class III patients.
About Heart Failure
More than five million Americans and about 26 million people
worldwide suffer from heart failure, which occurs when the heart is
unable to pump enough blood to the body. When this happens, blood
pressure eventually rises, leading to shortness of breath, fatigue,
swelling and other symptoms.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart failure disease management
with innovative solutions like the CardioMEMS HF System,
ground-breaking quadripolar technology and, in select European
markets, the HeartMate 3 left ventricular assist system and 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 or the
St. Jude Medical Pulse Blog.
Information for patients to learn more about heart failure can
be found at www.heartfailureanswers.com.
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
January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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version on businesswire.com: http://www.businesswire.com/news/home/20151109005582/en/
St. Jude Medical, Inc.Media RelationsKristi Warner,
651-756-2085kwarner@sjm.comorInvestor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.com
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