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ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., a global medical device company, today announced that an analysis of the benefits of using a Fractional Flow Reserve (FFR)-guided intervention in Belgium to determine the severity of blood flow blockages in patients coronary arteries can improve patient outcomes while saving millions of Euros.

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

In the context of the current Belgian health care model, use of the PressureWire™ technology to measure FFR:

  • Can prevent, on average, more than 60 avoidable deaths, more than 140 heart attacks and more than 245 major adverse cardiac events (MACE) in Belgium over two years
  • Could save the Belgian health care system nearly 4 million€ over two years
  • Potentially reduces treatment cost by an average of 950€ per patient in Belgium for Percutaneous Coronary Intervention (PCI), also known as coronary angioplasty
  • Improves quality-adjusted life expectancy for Belgian PCI patients

"It is rare in cardiology to find that a new technology not only prevents heart attacks and saves lives, but also substantially saves resources," said Prof. Uwe Siebert, M.D., MSc, M.P.H., ScD. "Though the FFR-guided strategy was determined to be cost saving in more than 99 percent of the results, the magnitude of the health benefits and cost savings from FFR measurement will depend on the willingness to make the use of the PressureWire technology the standard of care for patients with multivessel coronary disease."

The study was designed to determine the incremental cost-effectiveness of FFR-guided vs. angiography-guided PCI in patients with multivessel coronary artery disease in the context of Belgian health care system from the societal perspective. To conduct the analysis, original data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study was used. Results from the economic evaluation are based solely on the use of the St. Jude Medicals PressureWire™ Certus, a FFR measurement technology.

Previous analysis of the impact of FFR-guided treatment in Germany, France, Italy and the U.S. also revealed that use of the PressureWire technology can improve patient health while significantly saving money in the context of the current health care model for each respective country.

"Results in every country where an analysis has been conducted have demonstrated that FFR-guided therapy both improves patient outcomes and reduces cost to the health care system. With the PressureWire and other patient-benefitting technologies, St. Jude Medical is proud to help lead the way in improving the quality of life for patients and helping reduce the cost of health care in Belgium," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division.

The detailed economic analysis for Belgium was conducted by Prof. Uwe Siebert. The validity of the Belgian data modeling used for the analysis was verified by Dr. Bernard De Bruyne, Cardiovascular Center Aalst, OLV-Clinic-Aalst and Prof. Dr. Walter Desmet, University Hospitals Leuven.

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 patients ischemia, a deficiency of blood supply to the heart. The benefits of the PressureWire technology were recognized recently in the ESC/EACTS Guidelines with new recommendations for the treatment of coronary artery disease that support measuring FFR before deciding to perform PCI or send the patient to surgery in a wide range of patients.

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 Medicals PressureWire Certus technology exclusively for FFR measurement. The 12-month results, published in the Jan. 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, heart attack or repeat revascularization, were reduced by 28 percent 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 percent 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.

Posted by Sean Fenske, Editor-in-Chief, MDT

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