- New analysis from the CHAMPION trial
shows the CardioMEMS™HF System provides a 43% reduction in HF
hospitalizations and 53% improvement in survival of CRT/ICD class
III HF patients.
- An economic analysis of the entire
CHAMPION population demonstrates the CardioMEMS HF System is a cost
effective intervention
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced important new data presented during the
Heart Rhythm Society's (HRS) 36th annual Scientific Session
supporting improved outcomes and cost-effectiveness of the
CardioMEMS™ HF System for the management of Class III heart failure
patients.
CardioMEMS(TM) HF System. Courtesy of St.
Jude Medical (Photo: Business Wire)
A presentation during HRS 2015 included Pulmonary Artery
Pressure Management in Heart Failure Patients with Cardiac
Resynchronization Therapy or Implantable Cardioverter Defibrillator
Devices Significantly Reduces Hospitalizations and Mortality Above
and Beyond Background Guideline-Directed Medical Therapy. These
data were presented by Dr. William T. Abraham, co-primary
investigator of the landmark CHAMPION clinical trial, which
supported FDA approval of the CardioMEMS HF System.
The retrospective analysis showed that heart failure (HF)
management using pulmonary artery (PA) pressure monitoring improved
outcomes in patients already receiving optimal treatment including
both medical management with Guideline Directed Medical Therapy
(GDMT) and device therapy with an implantable rhythm device, such
as an ICD or CRT device.
“Even in patients being managed in accordance with American
College of Cardiology and American Heart Association guidelines for
medical management and device therapy, we saw a decrease in
all-cause hospitalizations and mortality for class III heart
failure patients when we added pulmonary artery pressure monitoring
with the CardioMEMS HF System,” said Dr. William Abraham, chief of
cardiovascular medicine at The Ohio State University Wexner Medical
Center. “These data show a 43 percent reduction in heart failure
hospitalizations and 53 percent reduction in mortality, which
demonstrates the added value of PA pressure monitoring in an
already well managed patient population.”
A new economic analysis of data from the CHAMPION trial showed
an Incremental Cost-Effectiveness Ratio (ICER) based on all-cause
comprehensive management of heart failure patients of $30,167 per
quality adjusted life year (QALY) gained when the patients were
managed by PA pressure monitoring. The ICER is a statistic used to
summarize the cost-effectiveness of a health care intervention. It
is defined by the difference in cost between two possible
therapeutic interventions, divided by the difference in their
effect on quality of life and survival. The analysis — Cost
Effectiveness Assessment of Pulmonary Artery Pressure Monitoring
for Heart Failure Management — was presented by Dr. Philip Adamson,
co-primary investigator of the landmark CHAMPION clinical
trial.
“These data, presented at HRS, show that the economic value for
pulmonary artery pressure monitoring is well below the U.S.
acceptable cost effectiveness threshold,” said Dr. Philip Adamson,
medical director and vice president of medical affairs for St. Jude
Medical. “We are encouraged by these analyses indicating that the
CardioMEMS HF System is a cost-effective solution.”
Additional CHAMPION trial data analysis presented at HRS 2015 by
Dr. Lee Goldberg from the Hospital of The University of
Pennsylvania evaluated patients from the CHAMPION trial and found
that heart failure hospitalizations were reduced the most when PA
pressures from the CardioMEMS™ HF System were used rather than
clinicians relying on clinical signs and symptoms alone. These
findings show that early intervention through the identification of
increased PA pressure weeks prior to clinical signs and symptoms,
significantly reduce HF hospitalizations. In addition, previously
presented data at AHA 2014 showed a 58 percent reduction in 30-day
all-cause readmissions when using the CardioMEMS HF System, which
can minimize a hospital’s risk of Medicare penalties due to
high-readmission rates.
About the CardioMEMS™ HF System
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
randomized, controlled CHAMPION clinical trial proved the
effectiveness of the CardioMEMS HF System in New York Heart
Association (NYHA) Functional Classification System class III
HF patients who had been hospitalized for HF in the previous 12
months. In contrast to large-scale studies of tele-monitoring of
weight, blood pressure and transthoracic impedance such as
Tele-HF, TIM-HF and DOT-HF, the CHAMPION study
showed that management based on PA pressures led to a clinically
significant reduction in HF admissions. Specifically, the trial
demonstrated a statistically and clinically significant 28 percent
reduction in the rate of HF hospitalizations at six months, and 37
percent reduction in HF hospitalizations during an average
follow-up duration of 15 months.
The CardioMEMS system uses a miniaturized, wireless monitoring
sensor that is implanted in the PA during a minimally invasive
procedure to directly measure PA pressure. Measuring PA pressure
allows clinicians to proactively manage treatment with medication
changes 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 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.
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’s Heart Failure Business
Approximately 26 million people worldwide suffer from heart
failure. St. Jude Medical collaborates with heart failure
specialists, clinicians and advocacy partners to provide
innovative, cost-effective solutions 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 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 April 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.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20150515005865/en/
St. Jude Medical, Inc.Investor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsKate Stoltenberg,
651-756-3388kstoltenberg@sjm.com
SJM (NYSE:STJ)
Historical Stock Chart
From Aug 2024 to Sep 2024
SJM (NYSE:STJ)
Historical Stock Chart
From Sep 2023 to Sep 2024