Healthcare Industry News:  neuromodulation 

Devices Interventional Cardiology

 News Release - April 29, 2011

St. Jude Medical Sponsored Study Determines FFR Can Improve Health while Reducing Economic Burden to German Healthcare System

On average more than 500 deaths and more than 1,300 heart attacks could be avoided with routine FFR use over two years

Nearly 14,000,000€ to the German healthcare system could be saved over two years


ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- 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.


Source: St. Jude Medical

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