Gore Completes Enrollment in REDUCE Clinical Study

W.L. Gore & Associates Inc. (Gore) has completed enrollment in its 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, M.D., professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and U.S. 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 United States, Canada, the United Kingdom, Denmark, Norway, Sweden, and Finland that enrolled a combined 664 subjects. All patients 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, Ph.D., head of Gore’s Structural Heart business unit.

The Gore Medical Products Division has provided therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million Gore medical devices have been implanted, according to the company. The Gore Medical Family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery.

W.L. Gore & Associates is headquartered in Flagstaff, Ariz.