St. Jude Occluder Misses Endpoint, Company Gets Predicted Form 483

St. Jude Medical announced Thursday that the company’s Amplatzer PFO Occluder has missed its primary endpoint in the RESPECT trial to evaluate the device’s success at reducing recurrent stroke risk. The trial was launched in 2003 and enrolled 980 patients at 69 centers. All patients had experienced strokes with no known cause before the trial commenced and were randomized to either Amplatzer or a medical management control arm.
Devices & Diagnostics Letter