May 26 2010
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.
SOURCE St. Jude Medical
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