St. Jude Initiates Trial - Analyst Blog

St. Jude Medical Inc. (STJ) has recently decided to initiate FAME trial to evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in seven countries, the UK, Germany, France, Italy, Switzerland, Belgium and Canada.

The study will also analyze FFR’s potential health and budget impact for each of these seven countries. The FAME (FFR vs. Angiography in Multivessel Evaluation) trial is a randomized, prospective, multi-center study. The trial was successfully concluded in the U.S. The trial enrolled 1,005 patients with multivessel coronary artery disease and compared the outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude’s product. 

Results indicated that in addition to superior clinical outcomes (which included 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%. 

FFR measurements are used to determine the severity of blood flow blockages in coronary arteries. This helps physicians identify the specific lesion or lesions responsible for a patient’s ischemia, known as a deficiency of blood supply to the heart caused by blood restriction. 

St. Jude is a leading designer, manufacturer and distributor of medical devices used for treating cardiovascular and neurological conditions. The company is a leader in the mechanical heart valve market. St. Jude’s closest competitors are Medtronic Inc. (MDT) and Boston Scientific Corporation (BSX). 

Currently, we are ‘Neutral’ on St. Jude.
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