W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients.
The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy.
“With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The value of closing PFOs has historically been debated, mainly due to a lack of sufficient data. We are enthusiastic that our positive Reduce study results allowed us to obtain an expanded FDA indication for this device and strongly believe the data show this is a prevention strategy for reducing the risk of recurrent ischemic stroke in patients with a PFO,” Gore medical products division leader David Abeyta said in prepared remarks.
Results from the trial were published in the New England Journal of Medicine last September, and showed a 77% reduction in recurrent ischemic stroke in patients who underwent PFO closures with the device in conjunction with antiplatelet therapy versus antiplatelet therapy alone.
Data also indicated a 49% relative reduction in cases of new brain infarcts, Gore said.
“The FDA approval of the Gore Cardioform septal occluder for PFO closure marks a significant milestone in the long journey to confirm the heart-brain relationship connecting PFO and stroke. The soft and conformable design of Gore’s device is ideal for providing long-term repair of PFOs of any shunt size. 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,” Reduce study investigator Dr. John Rhodes of the Medical University of South Carolina said in a prepared statement.
“The groundbreaking results of the Reduce study changed the neurology community’s perspective on PFO closure when they were announced. The Reduce study was the first U.S. investigational device exemption 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,” Reduce study investigator Dr. Scott Kasner of the University of Pennsylvania said in a press release.
In January, Gore announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study.