W. L. Gore & Associates (Gore) today provided an update on the Gore REDUCE Clinical Study, a prospective, randomised, multi-centre, multi-national trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen Ovale (PFO) closure in patients with history of cryptogenic stroke or imaging-confirmed Transient Ischemic Attack (TIA).
The unique study, which includes up to 50 investigational sites in the US, Denmark, Finland, Norway and Sweden, is on track to meet its estimated completion in 2015.
“We remain very confident that the Gore REDUCE Clinical Study will ultimately achieve its intended objective” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business.
The Gore REDUCE Clinical Study has several unique features, including the use of imaging-confirmed stroke/TIA for assessing its primary endpoint and the use of the GORE HELEX Septal Occluder. Additionally, the standardization of medical therapies across treatment arms will further aid the interpretation of the final results in assessing the potential benefit of device closure for the prevention of recurrent stroke.
The company is looking to expand their study to the UK, seeking to recruit British participants. MRI will be used to evaluate all patients in the trial to more accurately confirm the presence of stroke and TIA.
The GORE HELEX Septal Occluder was approved by the U.S. Food and Drug Administration (FDA) in 2007 for its pioneering method of treating Atrial Septal Defect (ASD), a congenital heart defect, with ePTFE, a biocompatible material that allows progressive tissue in growth, to help seal the defect.