FFR-guided intervention strategy can improve patient outcomes: Study

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.

“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”

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.