Consistent Evidence for Stroke Risk Reduction
The RESPECT trial has consistently shown a reduction in risk of recurrent cryptogenic stroke with the use of the AMPLATZER™ PFO Occluder in appropriate patients.1
The study enrolled 980 subjects, with 499 patients randomized to receive the AMPLATZER PFO Occluder (device group) and 481 randomized to receive standard-of-care medical management (medical management group). Researchers evaluated device group patients at approximately six months post implant by transesophageal echocardiogram to assess PFO closure.
Clinical evidence summary
RESPECT trial analysis supports a true device effect on recurrent ischemic stroke, explained by elimination of a conduit through which venous source emboli can travel to the brain.