Medical devices major
) will stop enrolling new patients in its FAME II clinical trial
following positive results from an interim analysis.
The independent data safety monitoring board ("DSMB")
recommended investigators to halt patient enrollment in the study
following the impressive results which have shown statistically
significant reduction in the need for hospital readmission and
urgent revascularization when fractional flow reserve
("FFR")-guided assessment is used in treating patients with
coronary artery disease.
FFR is an index that identifies and measures the severity of
coronary artery narrowing. It specifically locates the coronary
narrowings which are responsible for occluding blood flow to a
patient's heart muscle and directs the surgeons to identify the
lesions requiring stenting. The approach is believed to help rein
in healthcare costs and improve patient outcome.
The company-sponsored FAME II trial is evaluating the use of St.
Jude's PressureWire FFR devices during the treatment of patient
with stable coronary artery disease. The objective of the trial is
to study the role of FFR in treating this condition by comparing
FFR-guided percutaneous coronary intervention ("PCI") plus optimal
medical therapy ("OMT") with OMT alone.
The DSMB considered it unethical to continue randomize patients
to OMT alone as patients experienced a highly statistically
significant increased risk of hospital readmission and urgent
revascularization. The DSMB advised St. Jude to stop enrolling
patients in the FAME II study given the higher risk of major
adverse cardiac events in patients randomized to OMT alone versus
"FFR-guided PCI plus OMT". The board concluded that this difference
was highly unlikely to change with the enrollment of additional
St. Jude said that the FAME II trial will continue to track the
currently enrolled patients and will not add any new patients. The
trial has enrolled 1,219 patients in 28 centers across the U.S.,
Europe and Canada. The company plans to publish initial results
from the interim analysis this year.
Results from the original FAME trial showed that patients (with
multivessel coronary disease) who received FFR-guided treatment
experienced improved outcomes over time. The FAME II trial is
expected to further project the benefits of FFR-guided PCI and its
role in improving care for patients with coronary artery
With its LightLab acquisition in July 2010, St. Jude emerged as
the first company to offer a comprehensive lesion assessment
product portfolio that includes the FFR technology and Optical
Coherence Tomography ("OCT"), a next-generation imaging
St. Jude reckons FFR and OCT, the two exciting emerging
technologies, as the most important growth drivers in its vascular
business, allowing it to compete in a roughly $600 million market.
One of the company's key competitors in the FFR space is
). We are currently Neutral on St. Jude, which is in tandem with a
short-term Zacks #3 Rank (Hold).
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