St Jude Medical 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 said that the FFR measurements indicate the severity of blood flow blockages in the coronary arteries. Using the PressureWire Aeris or PressureWire Certus, the 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 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, the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14% in the US.
Frank Callaghan, president of the St Jude Medical’s Cardiovascular Division, said: “PressureWire FFR measurement technology represents a unique opportunity in medicine in which a product not only improves clinical outcomes, but also saves money. 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.”