St. Jude Medical STJ, a global medical device company, today
announced that Fractional Flow Reserve (FFR)-guided treatment using
PressureWire^™ was cost effective for coronary interventions when compared to
the best available medical therapy. Cost utility analysis data from the FAME
II trial was presented as a late-breaking clinical trial at the 24^th annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium,
sponsored by the Cardiovascular Research Foundation.
Three-year projected results derived from FAME II trial data revealed that
FFR-guided percutaneous coronary intervention (PCI) plus medical therapy had
an incremental cost-effectiveness ratio (ICER) of $32,000 per quality-adjusted
life year (QALY) compared to medical therapy alone in treating patients with
stable coronary artery disease. For comparison, a common threshold of $50,000
per QALY is often cited when evaluating the cost effectiveness of therapies.
Interventions with ICERs from $50,000 to $150,000 per QALY are thought to be
cost-effective and those below $50,000 per QALY are considered highly cost
effective per thresholds established by the World Health Organization. Results
reported in FAME II cost-effectiveness data are well below that threshold.
While FFR-guided PCI had a higher initial cost than patients treated by
medical therapy alone, after one year the cost gap narrowed by more than 50
percent due to a higher number of hospital re-admissions for patients treated
only with medical therapy.
Clinical results from the FAME II trial previously established that FFR-guided
PCI plus medication improves patient outcomes. Cost-effectiveness analysis
also found that the use of St. Jude Medical PressureWire^™ FFR measurement
technology (which measures blood flow restriction in the coronary arteries)
for patients treated with FFR-guided PCI plus medical therapy also
significantly improves quality of life indicators, such as freedom from angina
and chest pain.
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