ST. PAUL, Minn.–(BUSINESS
WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
announced today that an interim analysis of the FAME II trial has found a
highly statistically significant reduction in the need for hospital readmission
and urgent revascularization when Fractional Flow Reserve (FFR)-guided
assessment was used to direct treatment in patients with coronary artery
disease. As a result of the positive interim analysis, the FAME II independent
Data Safety Monitoring Board (DSMB) has recommended investigators stop patient
enrollment in this trial as the DSMB considers it unethical to continue to
randomize patients to optimal medical therapy (OMT) alone.

FFR is a physiological index used to determine the
hemodynamic severity of narrowings in the coronary arteries, and is measured
using St. Jude Medicals PressureWire™ Aeris and PressureWire™ Certus. FFR
specifically identifies which coronary narrowings are responsible for
obstructing the flow of blood to a patient’s heart muscle (called ischemia),
and guides the interventional cardiologist in determining which lesions warrant
stenting, resulting in improved patient outcomes and reduced healthcare costs.

The goal of the St. Jude Medical sponsored FAME II
(Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus
Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with
Stable Coronary Artery Disease) trial is to further study the role of FFR in
the treatment of stable coronary artery disease by comparing percutaneous
coronary intervention (PCI) guided by FFR plus OMT to OMT alone.

The DSMB recommended that St. Jude Medical stop patient
enrollment in its FAME II trial due to increased patient risk of major adverse
cardiac events (MACE) among patients randomized to OMT alone compared to
patients randomized to OMT plus FFR-guided PCI. In particular, patients
receiving OMT alone experienced a highly statistically significant increased
risk of hospital readmission and urgent revascularization, and the DSMB
determined that this difference was highly unlikely to change with inclusion of
more patients. The data currently reflect no observed difference in the rates
of death or heart attack.

The FAME II trial may provide new insights about the benefits
of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes
Utilizing Revascularization and Aggressive Drug Evaluation) trial, which
demonstrated no difference in the outcomes between PCI plus OMT compared to OMT
alone. However, the COURAGE study did not require use of PressureWire™ FFR
measurement technology.

“The FAME II trial is unprecedented in its ability to
provide further answers and evidence regarding the optimal way to treat
patients with coronary artery disease and myocardial ischemia,” said Bernard De
Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating
clinical investigator of the FAME II trial. “What we observed to date regarding
urgent revascularizations validates the profound role that FFR-guided therapy
has in improving patient outcomes. This is further evidence that FFR should be
considered the standard of care for patients with coronary artery disease.”

The FAME II trial will continue following patients currently
enrolled according to the trial protocol and will not enroll any new patients.
The trial randomized 1,219 patients with stable coronary artery disease in 28
centers in Europe, the U.S.
and Canada.

“The original FAME trial demonstrated that FFR guidance
improves outcomes in patients with stable coronary artery disease and two or
three vessel disease. Today, FAME II confirms that PCI is beneficial for
patients with one, two and three vessel disease whose ischemia has been
documented by FFR,” said Frank Callaghan, president of the St. Jude Medical
Cardiovascular Division. “Due to the statistically and clinically compelling
differences in the number of patients returning to the hospital for an urgent
revascularization procedure – which can be considered a surrogate for a repeat
heart attack or death – we support the recommendation of the DSMB and the
trials Steering Committee. We expect the data will continue to reveal the
important role that FFR plays in developing an optimal treatment strategy.”

Data will be published as information is analyzed, with
initial results expected to be presented in 2012.

About the Original FAME Trial

The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel
Evaluation) trial was a randomized, prospective, multi-center trial which
enrolled 1,005 patients with multivessel coronary artery disease. The FAME
study compared outcomes for patients whose treatment was guided by FFR to those
whose treatment was guided only by angiography using St. Jude Medicals
PressureWire Certus technology. The 12-month results, published in the Jan. 15,
2009 issue of the New England Journal of Medicine, demonstrated that instances
MACE were reduced by 28 percent for patients whose treatment was guided by FFR
rather than by standard angiography alone. Two-year results demonstrated that
patients who received FFR-guided treatment continued to experience improved
outcomes over time, including a 34 percent reduction in risk of death or heart
attack.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting
more control into the hands of those who treat cardiac, neurological and
chronic pain patients worldwide. The company is dedicated to advancing the
practice of medicine by reducing risk wherever possible and contributing to
successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn.
and has four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information, please
visit sjm.com.

Posted by Sean Fenske, Editor-in-Chief, MDT