St. Jude Medical Announces Initiation of a Study to Evaluate the Economic Impact of FFR in Europe and Canada

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today at EuroPCR it will evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in the UK, Germany, France, Italy, Switzerland, Belgium and Canada. The analysis will also determine FFR’s potential health and budget impact for each of the seven countries.

“St. Jude Medical will continue to conduct evaluations and sponsor research to better understand the broader economic and health care impact that FFR may have.”

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 detailed analysis will be based on the results of the FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature.

The research will reveal for each country:

Whether there is cost savings from using an FFR-guided approach to PCI
Whether there is a cumulative savings for the health care system annually
Whether there is an impact on health for the population undergoing PCI

The landmark FAME study, also sponsored by St. Jude Medical, compared treatment guided by FFR to standard angiography in more than 1,000 patients with multivessel coronary artery disease and found that in addition to superior clinical outcomes (which include a 34% reduction in death or heart attack), the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14% in the U.S.

The detailed analysis will be conducted by Professor Uwe Siebert, M.D., MSc, M.P.H., ScD and a FAME study investigator. Each country will also have local clinical advisors to help validate the data modeling.

“PressureWire FFR measurement technology represents a unique opportunity in medicine in which a product not only improves clinical outcomes, but also saves money,” said Frank Callaghan, president of the St. Jude Medical’s Cardiovascular Division. “St. Jude Medical will continue to conduct evaluations and sponsor research to better understand the broader economic and health care impact that FFR may have.”

EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.

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 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 myocardial infarction (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. The reduced healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.

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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