Gore releases statement in response to safety of GORE HELEX Septal Occluder for PFO closure in cryptogenic stroke patients


W. L. Gore & Associates (Gore) today released the following statement from the Gore REDUCE Clinical Study Principal Investigators on behalf of the Gore REDUCE Clinical Study Steering Committee in response to the recent CLOSURE I results presentation. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE® HELEX Septal Occluder for PFO closure in patients with history of cryptogenic stroke or imaging-confirmed Transient Ischemic Attack (TIA). The unique study includes up to fifty investigational sites in the US and Europe.

"On November 15, 2010 at the American Heart Association (AHA) annual meeting in Chicago, Anthony Furlan, MD presented the results of CLOSURE I, a prospective, multi-center, randomized controlled trial of PFO closure with the STARFLEX® Device (NMT Medical, Inc) versus best medical therapy for the prevention of recurrent stroke and/or transient ischemic attack (TIA) in patients with cryptogenic stroke / TIA and PFO. The results of the study, as presented, showed no statistically significant difference between device closure and best medical therapy. In a discussant presentation, Pierre Amarenco, MD concluded that PFO closure is not needed for the majority of patients with stroke and PFO and should not be performed in routine practice. However, he noted that many patients with stroke and PFO have alternative (non-PFO) causes for their strokes, and argued that this may have diluted a true causal effect of PFO in the CLOSURE I study. Dr. Amarenco left open the possibility that PFO closure may still be considered in patients with truly cryptogenic stroke.

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