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.)
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.”