Healthcare Industry News: embolic protection
News Release - October 10, 2008
W. L. Gore & Associates Receives FDA Approval for Gore EMBOLDEN Clinical Study
Multi-Center Study Will Evaluate the Safety and Efficacy of the GORE Embolic Filter in Conjunction with FDA-Approved Carotid StentsFLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced full approval from the US Food and Drug Administration (FDA) for the Gore EMBOLDEN Clinical Study1. 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.
“In the Gore EMBOLDEN Clinical Study, we will continue to advance carotid stenting and improve care for patients with carotid disease,” stated William A. Gray, MD, Columbia University Medical Center, national principal investigator for the study. “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 Study2 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.” The results of the Gore EMPiRE Clinical Study featuring the GORE Flow Reversal System will be presented at the 20th annual Transcatheter Cardiovascular Therapeutics scientific symposium, sponsored by the Cardiovascular Research Foundation on Thursday, October 16, 2008.
1 EMBOLDEN: Embolic Filter in Carotid Stenting for High Risk Surgical Subjects
2 EMPiRE: embolic protection with Reverse Flow Study of the Gore Flow Reversal System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com
Caution: Investigational Device. Limited by Federal (or United States) Law to Investigational Use.
Products listed may not be available in all markets pending regulatory clearance.
GORE is a trademark of W. L. Gore & Associates.
Source: W. L. Gore
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