St. Jude Medical Sponsored Study Determines FFR Can Improve Health while Reducing Economic Burden to German Healthcare System
April 29 2011 - 8:01AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that an analysis of the benefits to using
a Fractional Flow Reserve (FFR)-guided intervention strategy found
that the technology can improve patient outcomes while saving
millions of Euros. The analysis demonstrates that routine use of
FFR could reduce the number of deaths and heart attacks of German
citizens while also saving a potential 14,000,000€ in 2011 and
2012. The results of the economic analysis were announced at
Deutsche Gesellschaft fur Kardiologie in Mannheim, Germany.
The analysis, sponsored by St. Jude Medical, found that in the
context of the current German healthcare model, routine use of the
PressureWire™ to measure FFR:
- Can prevent on average more than 500
avoidable deaths, more than 1,300 heart attacks and more than 2,200
major adverse cardiac events (MACE) in Germany over two years
- Could save the German healthcare system
more than 3.3 million € in 2011 and more than 10.5 million € in
2012
- Potentially reduces treatment cost for
PCI per patient by an average of 333€ in Germany
- Improves quality-adjusted life
expectancy for German PCI patients
“It is rare in cardiology to find that a new technology not only
prevents major adverse cardiac events such as heart attacks and
saves lives, but also substantially saves resources,” said
Professor Uwe Siebert, M.D., MSc, M.P.H., ScD. “The magnitude of
the health benefits and cost savings from FFR measurement for the
German patients and health care payers depends on the willingness
to make the use of the PressureWire technology the standard of care
for patients with multivessel coronary disease. Our calculated mean
savings could be doubled under an optimal implementation
scenario.”
The study was conducted to determine the incremental
cost-effectiveness of FFR-guided vs. angiography-guided PCI in
patients with multivessel coronary artery disease in the German
health care system from the societal perspective. To do this,
original data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study was used. The FAME study, which
exclusively used the St. Jude Medical PressureWire, demonstrated
that routine use of FFR in the U.S. would reduce health care costs
by about $2,000 per patient as well as provide improved outcomes
for patients, including a 34% reduction in death or heart attack
after two years.
The detailed economic analysis for Germany was conducted by
Prof. Uwe Siebert. The validity of the German data modeling used
for the analysis was verified by Prof. Volker Klauss, Medizinische
Poliklinik, Campus Innenstadt, Klinikum der Universität München and
Dr. Ascan Warnholtz, II, Medizinische Klinik und Poliklinik der
Johannes Gutenberg-Universität Mainz.
Results from the economic evaluation are based solely on the use
of the St. Jude Medical FFR measurement technology, the
PressureWire™ Certus.
“Results in both the U.S. and Germany have demonstrated that FFR
both improves patient outcomes and reduces cost to the healthcare
system. St. Jude Medical is proud to play a part in helping reduce
the cost of healthcare in Germany for each patient as well as on a
societal basis,” said Frank J. Callaghan, president of the St. Jude
Medical’s Cardiovascular Division.
FFR measurements indicate the severity of blood flow blockages
in the coronary arteries. Using the PressureWire™ Aeris or
PressureWire™ Certus, this physiological measurement helps
physicians to better identify which specific lesion or lesions are
responsible for a patient’s ischemia, a deficiency of blood supply
to the heart caused by blood restriction. The benefits of the
PressureWire were recognized recently in the ESC/EACTS Guidelines
with new recommendations for the treatment of coronary artery
disease which support measuring FFR before deciding to perform PCI
or send the patient to surgery in a wide range of patients.
Incremental economic and healthcare impact results in France,
England, Italy, Switzerland, and Belgium will be announced in a
late breaking trial on Friday, May 20 at EuroPCR.
About the FAME Trial
The FAME study is a randomized, prospective, multi-center trial
which enrolled 1,005 patients with multivessel coronary artery
disease. The FAME study compared outcomes for patients whose
treatment was guided by FFR to those whose treatment was guided
only by angiography using St. Jude Medical’s PressureWire Certus
technology exclusively for FFR measurement. The 12-month results,
published in the January 15, 2009 issue of the New England Journal
of Medicine, demonstrated that instances of major adverse
cardiovascular events (MACE), including death, myocardial
infarction (heart attack) or repeat revascularization, were reduced
by 28% for patients whose treatment was guided by FFR rather than
by standard angiography alone.
Two-year results presented as a late-breaking trial during the
2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference
demonstrated that patients who received FFR-guided treatment
continued to experience improved outcomes over time, including a
34% risk reduction in death or heart attack. FFR-guided treatment
was also demonstrated to be cost-saving, with a difference per
patient of about $2,000, or 14%, between total healthcare costs for
the FFR-guided group and the group treated by angiography alone
after a year.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com.
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 1, 2011. 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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