St. Jude Medical CardioMEMS HF System is Now Guideline Directed Therapy for Heart Failure Patients in Europe
June 06 2016 - 8:00AM
Business Wire
European Society of Cardiology guidelines name the CardioMEMS™
HF System a recommended management tool allowing expanded access
for appropriately identified heart failure patients
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that its CardioMEMS™ HF System was added
to the European Society of Cardiology (ESC) guidelines as a
directed therapy management and monitoring tool for heart failure
patients. The new 2016 ESC Clinical Practice Guidelines for the
diagnosis and treatment of acute and chronic heart failure for the
first time include pulmonary artery pressure monitoring with the
CardioMEMS HF System.
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The CardioMEMS HF System uses a
miniaturized, wireless monitoring sensor that is implanted in the
pulmonary artery. (Photo: Business Wire)
Robust clinical data from the CHAMPION study was used to
establish this Class IIb recommendation for the CardioMEMS HF
System within the guideline directed therapy for heart failure
patients.
“The ESC guideline for the CardioMEMS HF System provides
direction for physicians who are working to appropriately treat our
heart failure patients and reduce their risk of repeated heart
failure hospitalizations,” said Dr. Giovanni Battista Perego from
Istituto Auxologico Italiano, Milan, Italy.
The data supporting this decision include evidence based on the
CHAMPION study and applies to all Class III heart failure patients
regardless of their ejection fraction (measurement of how much
blood is pumped out of the heart).
CHAMPION clinical data publications include:
- Wireless pulmonary artery hemodynamic
monitoring chronic heart failure: a randomized controlled trial
(The Lancet)
- Sustained efficacy of pulmonary artery
pressure to guide adjustment of chronic heart failure therapy:
complete follow-up results from the CHAMPION randomized trial
(Journal of the American College of Cardiology)
“We are very pleased to see the CardioMEMS HF System was
included in the guidelines and congratulate the European Society of
Cardiology for working to make this technology more widely
available to benefit patients living with heart failure,” said Dr.
Philip B. Adamson, medical director and vice president of medical
affairs for St. Jude Medical.
The CardioMEMS HF System is the first and only CE Mark
approved heart failure monitor that, when used by physicians, has
been shown to significantly reduce heart failure hospital
admissions and improve the quality of life in New York Heart
Association (NYHA) Class III patients. Long-term, prospective data
published in The Lancet supports the effectiveness of the
CardioMEMS HF System at reducing heart failure hospitalizations by
demonstrating the system can provide physicians with the
hemodynamic data to proactively manage their heart failure
patients.
The CHAMPION trial 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. The CardioMEMS HF System is the only proven
treatment for New York Heart Association (NYHA) Class III
Heart Failure patients who have a preserved Ejection
Fraction (HFpEF), which makes up
approximately half of all heart failure patients.
In addition, recently published data in Circulation: Heart
Failure showed that management with the CardioMEMS HF System
significantly reduced 30-day hospital readmission rates for
Medicare-eligible patients.
Approximately 23 million people worldwide are
afflicted with congestive heart failure and 2 million new cases are
diagnosed worldwide each year.
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 leading global medical device manufacturer
and is 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 employs approximately 18,000 people
worldwide and has five major areas of focus that include heart
failure, atrial fibrillation, neuromodulation, traditional cardiac
rhythm management and cardiovascular. 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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2016. 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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorKristi Warner, 651-756-2085Media
Relationskwarner@sjm.com
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