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news.W L Gore & Associates, a diversified multi-national manufacturing company, has announced that Peter Soukas, interventional cardiologist from Caritas St Elizabeth's Medical Center in Boston, Massachusetts, has enrolled the first patient in the Gore Embolden clinical study.
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The first patient was recently symptomatic and more than 90 years old. The greater than 95% 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.
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.
Stuart Broyles, leader of stroke interventions business unit at Gore, said: 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.
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.
The study for the Gore REDUCE Clinical Study will be conducted under John Rhodes, MD, Chief of Clinical Cardiology at Duke University Medical Center, and Scott Kasner, MD, Associate Professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center.