Gore wins expanded indications for Cardioform septal occluder

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 occlud...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

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