St. Jude took a hit last year when the RESPECT trial failed to meet its clinical endpoints, but the company wasn’t about to stop there.
The trial concluded that the Amplatzer heart implant failed to significantly reduce cryptogenic stroke compared with standard treatment with drugs, sending STJ shares sinking on Wall Street and putting fellow PFO closure devices makers on the defensive.
At this year’s International Stroke Conference 2013 in Honolulu St. Jude revisited the RESPECT trial, touting new findings that patients with the Amplatzer device had fewer and smaller strokes than patients who received drug therapy alone.
The results demonstrate that PFO closure may still be the right treatment for the right patients.
"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," St. Jude cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks.
The Amplatzer device was designed to treat a condition called patent foramen ovale, in which a naturally-occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.
St. Jude compared its Amplatzer against drug therapy in patients with recurrent cryptogenic stroke and PFO, reporting a non-statistically significant reduction of 50.8% in its primary endpoint when compared with drug therapy alone.