Gore obtains FDA approval for clinical study of embolic filter

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 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 Gray, 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, product specialist at Gore, said: “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.”