St. Jude Medical, Inc. (NYSE:STJ), a medical device company, today announced results from its RESPECT trial, which studied the AMPLATZER™ PFO Occluder in the prevention of recurrent cryptogenic stroke. Evidence presented at a late breaking trial session during the 24 th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, shows that the primary analysis was not statistically significant but trended towards superiority, while additional analyses demonstrated superiority. Stroke risk reduction was observed across the totality of analyses with rates ranging from 46.6 percent - 72.7 percent.
According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the U.S. an estimated $53.9 billion in health care services, medications and missed days of work. Approximately 87 percent of all strokes are ischemic, which occur when blood clots block the blood vessels to the brain. Up to 40 percent of ischemic strokes are classified as cryptogenic, a stroke of unknown cause, and the prevalence of PFO is up to three times greater in this population.
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.
“The patient population affected by cryptogenic stroke tends to be relatively young and healthy. PFO closure with the AMPLATZER PFO Occluder is potentially a novel prevention strategy that may be superior to medications alone,” said Dr. John D. Carroll, director of the Cardiac and Vascular Center and Interventional Cardiology at the University of Colorado, who presented the data at TCT. “Stroke is a devastating disease and we now have compelling evidence that shows a 46 to 72 percent risk reduction in recurrent strokes, which is meaningful for this otherwise healthy patient population with a long life expectancy.”