W.L. Gore & Associates, Inc. (Gore) today announced completion of enrollment for the Gore REDUCE Clinical Study, a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE® HELEX® Septal Occluder and GORE® Septal Occluder for PFO closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA).
“With enrollment in the REDUCE Study now complete, we move one major step closer to providing additional evidence on the best treatment for stroke patients with PFO,” said Scott Kasner, MD, Professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and US Neurology Principal Investigator for the REDUCE Study. “Prior studies have left us with substantial uncertainty regarding the role of PFO closure in reducing recurrent stroke risk. We are confident that the rigorous approach to patient selection and the optimized design of the REDUCE Study will provide robust and reliable data to inform clinical decision making in this patient population.”
The study includes 65 investigational sites in the US, Canada, UK, Denmark, Norway, Sweden, and Finland that enrolled a combined 664 subjects. All subjects will complete a minimum of two years of follow-up evaluations before analysis of the study endpoints.
“Completing enrollment in the REDUCE Study marks an important milestone in Gore’s efforts to develop clinical data that will benefit patients and clinicians. We believe the REDUCE Study will make an important contribution to understanding the therapeutic options for patients with cardiovascular and cerebrovascular disease,” said Jared Parker, PhD, Gore Structural Heart Business Leader.