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St. Jude Medical, Inc.
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.
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.
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