GORE CARDIOFORM Septal Occluder Approved by FDA for PFO Closure

The FDA has approved the GORE CARDIOFORM Septal Occluder for patent foramen ovale (PFO) closure procedures that have shown to reduce the chance of stroke in some patients. The CARDIOFORM is already being used in the U.S. for closing of atrial septal defects up to 17 millimeters in size.

The catheter-delivered device consists of two discs that make contact with the tissue walls on both sides of the PFO and come together to block the passage of blood between the atria.

“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, Medical University of South Carolina, and U.S. Interventional Cardiologist National Principal Investigator for the REDUCE Study that evaluated the CARDIOFORM for PFO closure procedures. I am pleased that a device I have grown to trust for ASD closure is now FDA approved for PFO closure as well. I am also impressed with the rate of serious adverse events in the REDUCE Study, which showed no significant difference in risk between closure and medical therapy alone. The clear reduction in recurrent ischemic stroke provided by PFO closure far outweighs the low risk of serious adverse events.”

“The groundbreaking results of the REDUCE Study changed the neurology community’s perspective on PFO closure when they were announced,” said Scott Kasner, MD, Neurologist in the Perelman School of Medicine at the University of Pennsylvania, and U.S. Neurology National Principal Investigator for the REDUCE Study. “The REDUCE Study was the first U.S. Investigational Device Exemption (IDE) study to show a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis. It was also the first study to show PFO closure reduces new brain infarct. I am excited that the GORE CARDIOFORM Septal Occluder is now FDA approved for PFO closure and believe these data prove the value of closing PFOs to prevent recurrent ischemic stroke when utilized in an appropriate patient population.”

Here’s a silent animation from GORE explaining the placement of the device:

Product page: GORE CARDIOFORM Septal Occluder…

Link to details on the REDUCE study…

Via: GORE…