Get Closure for Your Patients
The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients predominately between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
Safe. Effective. Reproducible.
With the AMPLATZER PFO Occluder, you have access to a safe, effective and reproducible solution for PFO patients at risk for recurrent ischemic stroke. Both the device and procedure are:
- Safe: Data from the RESPECT clinical trial showed low rates of Serious Adverse Events (SAEs) related to the device (2.0%) and procedure (2.4%) for the Device group.1
- Effective: Long-term follow-up data (average 5.9 years) from the RESPECT clinical trial shows a significant 45% relative risk reduction in favor of PFO closure with the AMPLATZER PFO device for prevention of any recurrent ischemic stroke, and a 62% relative risk reduction for prevention of recurrent ischemic stroke of unknown mechanism (cryptogenic).2
- Reproducible: 99% technical success and 96.1% procedural success.1
Leading Innovation in Structural Heart Disease
The AMPLATZER™ PFO Occluder is part of our structural heart occlusion portfolio. Our vision is to transform the treatment of structural heart disease by offering minimally invasive technologies designed for conformity and complete closure. Read more about the portfolio and our approach to structural heart disease.