Device Overview

What is the AMPLATZER PFO Occluder?
The AMPLATZER PFO Occluder consists of two wire-mesh discs, filled with polyester fabric, that closes a patent foramen ovale (PFO). A doctor implants the device using a catheter. A catheter is a sterile, flexible, hollow tube that is inserted in the patient's groin and navigated through large veins to the heart. The procedure lasts about one to two hours. Most patients leave the hospital within 24 hours.

The U.S. Food and Drug Administration (FDA) considers the AMPLATZER PFO Occluder an experimental or investigational device. It is limited by Federal (or United States) law to investigational use.

For a list of participating cardiologists and neurologists involved in the RESPECT Trial, go to physician locator.