Results of St. Judge's RESPECT Trial Published in New England Journal of Medicine

St. Jude Medical, Inc.

, 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.