St. Jude Medical (NYSE:STJ) is launching a study to examine the economics of coronary interventions using fractional flow reserve in Japan, China, India, Korea, and Australia.
The analysis, based on the results of the Fame trial comparing FFR-guided procedures with those guided by angiography, plus statistics from country-specific percutaneous coronary intervention registries and other studies.
It aims to put some numbers on any cost savings the FFR approach might generate, as well as the cumulative savings for the health care system and the impact on outcomes following FFR-guided PCIs.
St. Paul, Minn.-based St. Jude funded a similar effort in Europe, which it said demonstrated improved patient health and lower costs.
"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 (~$658) and €950 (~$1,250) per patient, depending on the country," according to a press release. "Additionally, previous economic analysis determined that an FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14%, in the context of the U.S. health care system."
Fractional flow reserve is a measurement of the pressure drop across a narrowed portion of blood vessel, used to help determine the severity of the restriction. St. Jude got into the FFR game in 2008, when it paid $250 million to acquire Radi Medical System AB, a Swedish guidewire maker. In January, the company halted the Fame II trial after an independent safety advisory board recommended it be stopped due to strong positive results. The trial, which compared stenting accompanied by FFR measurement with optimal medical care in treating coronary artery disease, was stopped because of “a highly statistically significant reduction in the need for hospital readmission and urgent revascularization” for the FFR patients, according to St. Jude.
The company is also first out of the gate with a hybrid FFR/OCT blood vessel imaging system, which won CE Mark approval in the European Union in July 2011 and gained 510(k) clearance from the FDA last October.
St. Jude is embroiled in a legal battle with its main rival in the FFR market, Volcano Corp. (NSDQ:VOLC), over FFR device patents. And there’s a new kid on the block with a potentially disruptive technology, Redwood, Calif.-based HeartFlow, which is developing a non-invasive method of detecting FFR using angiography scans.