W. L. Gore receives FDA approval for Gore EMBOLDEN Clinical Study


W. L. Gore & Associates announced full approval from the US Food and Drug Administration for the Gore EMBOLDEN Clinical Study. The Gore EMBOLDEN Clinical Study is a prospective, multi-center, non-randomized, single-arm study designed to evaluate the safety and efficacy of the GORE Embolic Filter for neuroprotection during carotid artery stenting (CAS) in patients at high risk for carotid endarterectomy. The primary endpoint is a composite major adverse event rate of death, stroke, and myocardial infarction at 30 days post-procedure.

William A. Gray, MD, Columbia University Medical Center, national principal investigator for the study said, In the Gore EMBOLDEN Clinical Study, we will continue to advance carotid stenting and improve care for patients with carotid disease. Based on the demonstrated filter efficiency of the GORE Embolic Filter, we hope to produce positive results and progress the field even further.

Mary Mulder, PhD, Product Specialist at Gore, explained: The GORE Embolic Filter enhances traditional filter designs by using a unique diamond frame to minimize the risk of emboli passing between the filter frame and the vessel wall, even in tortuous anatomy. To take full advantage of improved filter efficiency, the filter is designed to easily navigate tortuous vessels with small landing zones and tight curves, similar to a bare guidewire.

The GORE Embolic Filter joins the company’s unique flow reversal technology to augment Gore’s carotid embolic protection solutions. Dr. Gray, who was also an investigator in the Gore EMPiRE Clinical Study** evaluating the GORE Flow Reversal System stated, The GORE Embolic Filter is a promising addition to Gore’s expanding carotid portfolio. Having multiple embolic protection options will allow clinicians to customize the neuroprotection decision for each CAS patient.