Abbott developed the AMPLATZER™ PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain.
The safety and effectiveness of the AMPLATZER™ PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER™ PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER™ PFO Occluder received market approval by FDA on October 28, 2016.
The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER™ PFO Occluder in a post approval setting.