Flagstaff, AZ (January 16, 2009) – W. L. Gore & Associates (Gore) today announced that Peter A. Soukas, MD, interventional cardiologist from Caritas St. Elizabeth's Medical Center in Boston, Massachusetts, enrolled the first patient in the Gore EMBOLDEN Clinical Study* on January 6, 2009.
The first patient was recently symptomatic and greater than 90 years old. The greater than 95 percent stenosis in the internal carotid artery was successfully stented under protection by the GORE Embolic Filter. The patient was discharged from the hospital and is doing well.
Dr. Soukas commented, "In spite of the near total occlusion, the GORE Embolic Filter crossed easily and provided a stable platform for the remainder of the procedure. Moreover, the filter captured an impressive amount of embolic debris. One particularly large particle of plaque that was retrieved by the device would likely have put the patient at risk for a symptomatic event."
"We are pleased to get this important study underway," commented William A. Gray, MD, Columbia University Medical Center, national principal investigator for the Gore EMBOLDEN Clinical Study. "Key device attributes, including low crossing profile, smooth tip transitions and reliable vessel wall apposition, were in evidence and proved beneficial in this challenging case."
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 GORE Embolic Filter incorporates a unique diamond frame. The diamond frame is designed to optimize vessel wall apposition and filter efficiency, even in tortuous vessels with small landing zones and tight curves. The GORE Embolic Filter expands Gore's neuroprotection portfolio and compliments the company's distinctive flow reversal technology.
"Improving patient safety is a primary goal of Gore, as exemplified by not only the Gore EMBOLDEN Clinical Study, but also the GORE Flow Reversal System and Gore EMPiRE Clinical Study**," added Stuart Broyles, PhD, Stroke Interventions Business Unit Leader at Gore. "We are pleased with the patient outcome in this initial case and excited that carotid interventionalists are expressing such a high level of interest in the study."
* EMBOLDEN: GORE Embolic Filter in Carotid Stenting for High Risk Surgical Subjects
** EMPiRE: Embolic Protection with Reverse Flow Study of the GORE Flow Reversal System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy
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 goremedical.com.
Shannon Murphy /Andrea Hawley
Schwartz Communications, Inc. for W. L. Gore & Associates
415-512-0770
GoreMedical@schwartz-pr.com
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