Image: A lightweight occluder closes defects in the heart (Photo courtesy of Gore).
An innovative occlusion device facilitates permanent closure of atrial septal defects (ASD) and patent foramen ovale (PFO), including challenging defects.
The Gore Medical Products (Gore; Flagstaff, AZ, USA) Cardioform Septal Occluder is a transcatheter-delivered device comprised of two independent conformable discs that span and cover the heart's anatomy to close defects. Each disc consists of a platinum-filled nitinol wire frame covered with a thin expanded polytetrafluoroethylene (ePTFE) membrane coated with a hydrophilic surface treatment (facilitating echocardiographic imaging). When fully deployed, the Occluder assumes a double-disc configuration to prevent shunting of blood through the defect.
The delivery system consists of a 75 cm working length 10 Fr catheter that is coupled to a handle that facilitates loading, deployment, and locking of the Occluder; the handle also allows repositioning and retrieval, if necessary. The Occluder is available in diameters of 15, 20, 25, and 30 mm, and can be used to close defects of up to 17 mm. Once in position, the Occluder provides optimal apposition to the surrounding anatomy for immediate closure, together with rapid endothelialization and lasting long-term performance.
“The soft and conformable design of Gore's device is ideal for providing long-term repair of PFOs of any shunt size,” said John Rhodes, MD, of the Medical University of South Carolina (MUSC; Charleston, USA). “I am pleased that a device I have grown to trust for ASD closure is now FDA approved for PFO closure as well. The clear reduction in recurrent ischemic stroke provided by PFO closure far outweighs the low risk of serious adverse events.”
When the chambers of a human heart begin to develop, a tunnel is formed between the right and left atria of the heart in order to allow blood to flow directly from the venous to the arterial circulation, circumventing the non-functioning fetal lungs. Following birth, a pressure differential between the right and left atria forms to allow blood flow to the fully functioning lungs, and the tunnel eventually closes completely. When this does not occur, a PFO is formed, allowing blood clots and deoxygenated blood to cross over to the arterial side.
Gore Medical Products