A clinical trial evaluating St. Jude Medical Inc's implantable device used to prevent stroke in patients who have a common congenital heart defect failed to achieve its main goal. St. Jude, which paid for the 980-patient study, said it used the trial data to file for U.S. regulatory approval and submitted an application to the U.S. Food and Drug Administration in the fourth quarter of 2012. The device, a permanent implant, is used on people who have a hole in the wall that separates the left and right upper chambers, of the heart. Everyone has a hole present at birth, but it never closes in about one-quarter of the population, according to the National Institutes of Health. The hole - called a patent foramen ovale, or PFO as it is more commonly known - raises the risk of stroke. It usually is not treated unless a blood clot causes a stroke, or if there are other heart problems. When relatively young people have a stroke without an identifiable cause, a PFO is often suspected. Dr. Jeffrey Saver, director of the UCLA Stroke Center and one of the lead investigators of the study, dubbed RESPECT, said the trial demonstrated that implanting the device in the heart is likely a better strategy for reducing stroke than just using anti-clotting medication, such as aspirin or Warfarin. "It's not formally a positive trial; it missed the primary endpoint," Saver said in a telephone interview.
