Cost Effectiveness Study Determines FFR Can Improve Health while Reducing Economic Burden in UK, France and Italy

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 significant amounts of money. Full results for the UK, France and Italy and preliminary results in Switzerland and Belgium were announced at a Late Breaking Trial session today at EuroPCR.

The analysis, which was funded by an educational research grant from St. Jude Medical, found that within each of the country’s respective health care systems, the FFR-guided approach is cost-saving, meaning that use of FFR improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using angiography alone.

The magnitude of health and budget impact strongly depends on assumptions about the cost of cardiovascular care in each country and local clinical conditions. Additionally, in each country the use of the PressureWire™ technology improved the quality-adjusted life expectancy for PCI patients.

"In each region where this economic analysis was conducted, the PressureWire was found to both improve clinical outcomes by increasing quality-adjusted life years and reducing the number of cardiac events and save a substantial amount of resources,” said Professor Uwe Siebert, M.D., M.Sc., M.P.H., Sc.D., from the Health and Life Sciences University of Hall (Austria), who led the research project. "Our research reveals that the magnitude of the health benefits and cost savings from FFR measurement for the European patients and health care payers could be even more significant under an optimal FFR implementation scenario.”

Specifically, in the context of the current healthcare model for each respective country, the analysis found:

In the United Kingdom FFR use:

• Can prevent on average more than 30 avoidable deaths, more than 70 heart attacks and more than 120 major adverse cardiac events (MACE) over two years
• Could save the British healthcare system more than 300,000£ in 2011 and more than 800,000£ in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 600£ in the UK

In France FFR use:

• Can prevent on average nearly 300 avoidable deaths, nearly 700 heart attacks and about 1,200 MACE in France over two years
• Could save the French healthcare system more than 5 million€ in 2011 and more than 11 million€ in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 900€ in France

In Italy FFR use:

• Can prevent on average more than 120 avoidable deaths, more than 300 heart attacks and more than 520 MACE in Italy over two years
• Could save the Italian healthcare system more than 800,000€ in 2011 and more than 3 million€ in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 500€ in Italy

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 various health care systems in question from the societal perspective. To do this, original patient-level data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study were used.

"Results in both the U.S. and now in Europe have demonstrated that FFR both improves patient outcomes and reduces cost to the healthcare system. With healthcare system finances under pressure everywhere, we are proud to offer a technology that relieves European health care systems from financial pressure and that protects and saves the lives of European patients,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division.

The methodology of the data analysis in each country was verified by local physicians.

Preliminary results in Belgium and Switzerland also reveal a trend towards cost-savings. The full report for these countries will be revealed later this year.

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 FFR were recognized in the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Guidelines with new recommendations for the treatment of coronary artery disease which support measuring FFR in a wide range of patients before performing PCI or recommending surgery.

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.

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.

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