February 11, 2013 - St. Jude Medical, a healthcare products company based in Little Canada, Minnesota, announced that it had taken a second look at clinical data from its unsuccessful RESPECT study. According to the company, results from the failed clinical trial still show some promise for St. Jude’s Amplatzer patent foramen ovale closure device.
Initially, St. Jude viewed the RESPECT trial as a failure. The clinical trial concluded that the Amplatzer heart implant demonstrated limited efficacy in reducing the risk of cryptogenic stroke following implant compared to pharmaceuticals. This caused St. Jude’s stock to plummet in the days following the announcement.
However, St. Jude revisited the trial at the 2013 International Stroke Conference in Honolulu, Hawaii. According to the “revisited” results, patients who underwent Amplatzer implantation experienced smaller strokes than those who received drug therapy on its own.
Frank Callaghan is the CEO of St. Jude Medical. In prepared remarks, he said, "The overall trial demonstrates that PFO closure with the Amplatzer PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke."