Gore Provides Update on REDUCE PFO Study

July 8, 2010—W. L. Gore & Associates (Flagstaff, AZ) provided an update on the Gore REDUCE clinical study, a prospective, randomized, multicenter, multinational trial designed to show the 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 study includes up to 50 investigational sites in the United States, Denmark, Finland, Norway, and Sweden and is expected to meet its estimated completion in 2015.

Gore stated that it was emphasizing its commitment to the REDUCE study because of the recently announced preliminary data from the CLOSURE I trial. The company reiterated its confidence in REDUCE's design, expected outcome, and intended objective.The REDUCE trial's findings will be used to pursue a US Food and Drug Administration (FDA) indication for the Gore Helex septal occluder for PFO closure and the prevention of recurrent stroke. In 2007, the FDA approved the Gore Helex for treating atrial septal defect.

The study's United States Neurology Principal Investigator, Scott Kasner, MD, commented, “The design of the Gore REDUCE clinical study is unique from the other PFO stroke trials in several respects. First, magnetic resonance imaging of the brain will be performed on all patients at baseline and at 2 years. This feature offers an additional imaging endpoint for making comparisons between the treatment arms. Second, it focuses on secondary prevention of stroke rather than TIA, which improves the reliability of the study outcomes and measurably impacts the public health. Finally, this is a multinational study, which enhances its global applicability. These efforts will likely help resolve the open debate about whether PFO closure is a viable option for treating cryptogenic stroke/TIA patients as compared to medical treatment alone, as it is used today.”

On June 17, NMT Medical, Inc. (Boston, MA) announced that the preliminary results for the CLOSURE I trial in the United States indicated that it did not achieve its primary endpoint, which was to show that PFO closure with the company's StarFlex technology was superior to the current best medical therapy for preventing recurrent strokes and TIAs. The preliminary results indicated that closure with StarFlex provided a small but not statistically significant benefit over the current best medical therapy.

The trial's preliminary results also indicate that the safety profile of the StarFlex device had a low rate of complications similar to that of the current best medical therapy. In addition, there was a very low rate of thrombus formation. Closure rates in the trial were 86.5%, which is consistent with NMT's previously reported results for the StarFlex implant and is in line with other transcatheter closure devices.

NMT stated that it is in discussions with the FDA to evaluate the company's possible next steps relating to the stroke/TIA indication. NMT is working with its clinical investigators, contract research organization, and the CLOSURE I executive committee to analyze the full trial data set to help better understand and evaluate the clinical and regulatory options. The company expects that full data results will be discussed at the American Heart Association's Scientific Sessions in November 2010. NMT also advised that the CLOSURE I results do not impact the device's current FDA and CE Mark approvals for ventricular septal defect and atrial level shunt.