St.Jude Places Stake In The Ground By Supporting Economic Analysis Of FFR In Asia and Australia

In short

St. Jude Medical, Inc. has announced plans to evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia. The analysis will determine the potential health and budget impact that FFR-guided treatment provides for each of the countries, with the aim of improving the health, welfare, and quality of life for the billions of people residing in these countries.


FFR measurements indicate the severity of blood flow blockages in the coronary arteries. They can be taken using St Jude’s PressureWire™ Aeris or PressureWire™ Certus. This physiological measurement identifies which coronary narrowings are responsible for heart muscle ischemia, and guides the physician in determining which lesions warrant stenting.

The detailed analysis will be based on the methodology used in the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, published in early 2009 and demonstrating that FFR guided treatment outperformed Angiography in terms of outcome and incidence of death or heart attack.  This study will be informed by statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature.

The research will reveal for each country the cost savings from using an FFR-guided approach to PCI, any cumulative savings for the health care system annually and most significantly the impact on health for the population undergoing PCI

Previous study shows FFR can improve patient health while saving money

St. Jude Medical provided an educational grant for similar research in Europe, with results revealing that the impact of FFR-guided treatment using the PressureWire technology can improve patient health while also significantly saving money. The analysis indicated that within the health care systems of Germany, the U.K., France, Italy and Belgium that the FFR-guided approach has the potential to reduce deaths and heart attacks as well as save between 500€ and 950€ per patient, depending on the country. Additionally, previous economic analysis determined that an FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14 percent, in the context of the U.S. health care system.

Company comments

“All of the research that has been conducted in the U.S. and Europe regarding the benefits of using our PressureWire FFR measurement technology indicates that it improves clinical outcomes and saves money; we hope to discover similar outcomes in the Asian and Australian markets,” said Frank J. Callaghan, president of St. Jude Medical Cardiovascular Division. “FFR represents a unique opportunity in medicine that aligns with the needs of government – to help make healthcare more affordable, and physicians – to improve care.”

Clinician comments

According to the company press release the detailed analysis will be funded by an educational research grant from St. Jude Medical and led by professor Uwe Siebert, M.D., MSc, M.P.H., ScD and a FAME study co-author. Each country will also have local clinical advisors to help validate the data modeling.

“We believe that conducting this research will enable a better understanding of the broader economic and health impact that FFR-guided therapy may provide,” Siebert said. “Having this knowledge on hand will help provide physicians, hospitals and governments with the information they need to decide on treatment options for ideal patient care.”

Source: St Jude Medical