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Results of St. Jude Medical's RESPECT Trial Published in The New England Journal of Medicine



  Results of St. Jude Medical's RESPECT Trial Published in The New England
  Journal of Medicine

Eight-year study confirms PFO closure was superior to medical therapy alone in
reducing risk of recurrent stroke in prespecified per-protocol and as-treated
cohorts

Business Wire

ST. PAUL, Minn. -- March 20, 2013

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced publication of results from its landmark RESPECT trial in The New
England Journal of Medicine. The study results show that device closure using
the AMPLATZER™ PFO Occluder is superior to antiplatelet medications or
warfarin in preventing recurrent cryptogenic stroke (a stroke from an unknown
cause) in patients with a common heart defect called a patent foramen ovale
(PFO), as measured in the prespecified per-protocol and as-treated patient
cohorts of the trial. Patients in the study had a 51 to 73 percent risk
reduction in recurrent strokes when evaluated across prespecified measures.

Photo of AMPLATZER PFO Occluder. (Photo: St. Jude Medical, Inc.)

Photo of AMPLATZER PFO Occluder. (Photo: St. Jude Medical, Inc.)

Normal in a developing fetus, the foramen ovale allows oxygenated blood from
the placenta to bypass the lungs. This small, flap-like opening typically
closes shortly after birth. When this flap remains open, or patent, it is
referred to as a PFO. A PFO can potentially allow dangerous clots to pass from
the right side of the heart to the left, travel up to the brain and cause a
stroke. Studies show that nearly half of all people who suffer a cryptogenic
stroke also have a PFO.

“The results of this landmark study are clinically important as we continue to
search for solutions for young and middle-aged patients with a long-life
expectancy, who are at risk of having a second stroke. The RESPECT trial data
shows device closure with the AMPLATZER PFO Occluder, in carefully selected
patients, is quite safe, effective in closing the PFO, and lowers the risk of
recurrent stroke in two of the three patient cohorts,” said Dr. John D.
Carroll, director of the Cardiac and Vascular Center and Interventional
Cardiology at the University of Colorado Hospital and lead author of the
journal article. “The reduction in stroke achieved in the PFO-closure group
exceeds that of several well-established pharmacologic treatments for the
prevention of secondary strokes.”

Conducted over the course of eight years at 69 medical centers in the U.S. and
Canada, the RESPECT study followed 980 participants who had suffered a
cryptogenic stroke that was confirmed by stroke neurologists using routine
imaging technologies. The average age of the patients in this trial was
46-years old. The trial was a prospective, controlled, randomized (1:1) study
in which patients were randomly assigned to either the device group or the
medical group. The primary efficacy endpoint was defined as the composite rate
of recurrent nonfatal stroke, fatal ischemic stroke or death after
randomization. Enrollment was stopped once 25 events occurred, all of which
were non-fatal recurrent stroke, as measured across all patients in the study.

Patients in the device group underwent a procedure in which their PFO was
closed with the Amplatzer PFO Occluder followed by six months of medication
therapy. In the medical group, four standard-of-care medical therapy regimens
were used throughout the study: aspirin, warfarin, clopidogrel and aspirin
combined with extended release dipyridamole.

Analyses were conducted on the intent-to-treat population, which included all
patients according to the group to which they were randomly assigned, though
some patients in the device group did not receive the randomized treatment. A
difference in the dropout rate between the medical therapy group and the
device group challenged the validity of the primary intent-to-treat raw count
analysis, which did not meet statistical significance. Using the same
intent-to-treat cohort in a time-to-event analysis demonstrated a risk
reduction of greater than 50 percent, which trended towards statistical
superiority with a p-value of 0.08.

The study protocol also prespecified that if dropout rates differed
significantly between the medication and device groups that analyses of two
additional cohorts would be evaluated. These included:

  * Per-protocol cohort – patients who received the randomly assigned
    treatment and adhered to the protocol-mandated medical treatment
  * As-treated cohort – patients who received and adhered to a
    protocol-approved treatment and were classified according to the treatment
    they actually received

Device closure was superior to medications alone in these two prespecified
analyses with a low rate of associated risks. There were no statistically
significant differences in the incidence of any serious adverse event between
the two groups.

“The analysis of the data from patients in the per-protocol group and the
as-treated group provide compelling evidence that PFO closure with the
AMPLATZER PFO Occluder is superior to medical management from both clinical
and statistical perspectives,” said Frank J. Callaghan, president of the St.
Jude Medical Cardiovascular and Ablation Technologies Division. “The totality
of evidence from this study, including the strong performance and safety
profile of the device, demonstrates the compelling clinical benefits of
closure versus medical management in reducing the likelihood of recurrent
stroke in this patient population.”

According to the World Health Organization (WHO) an estimated 15 million
people worldwide suffer from stroke each year. Of these, 5 million die and
another 5 million are left permanently disabled, placing a burden on families
and communities. It is estimated that 87 percent of all strokes are ischemic
strokes, which occur when blood clots block the blood vessels to the brain. Up
to 40 percent of ischemic strokes are classified as cryptogenic, which means
the cause of the stroke is unknown.

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.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. Such forward-looking statements include the expectations, plans
and prospects for the Company, including potential clinical successes,
anticipated regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by the
Company are based upon management’s current expectations and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors beyond the
Company’s control and the risk factors and other cautionary statements
described in the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the Company’s Annual
Report on Form 10-K for the fiscal year ended December 29, 2012. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.

Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20130320006618/en/

Multimedia
Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50595033&lang=en

Contact:

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Denise Landry, 972-309-8085
dlandryr@sjm.com
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