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I N T H E N E W S Gore Acquires Intellectual Property of NMT Medical, Inc. CLOSURE I Trial Data May Create Better Clinical Understanding of Patent Foramen Ovale (PFO) in Stroke Patients FLAGSTAFF, Arizona — October 19, 2011 — W. L. Gore & Associates (Gore) announced that the Company has purchased the assets and intellectual property of NMT Medical, Inc., including the data related to 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. “We made the decision to acquire these assets in the spirit of collaboration and in the interest of advancing scientific and medical understanding,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. The study data were acquired with the rest of the NMT assets, but the transaction did not transfer any liabilities or regulatory obligations of NMT. The acquisition came after NMT ceased operations earlier this year. ABOUT W. L. GORE & ASSOCIATES The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive 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. Gore was recently named one of the best companies to work for by Fortune magazine for the 14th consecutive year. For more information, www.goremedical.com.
Gore Receives Zero Reports of Erosion Associated with GORE ® HELEX ® Septal Occluder Worldwide Data Provides Confidence in Device as Permanent Heart Implant On August 22, 2011, W. L. Gore & Associates (Gore) reported that it has received zero accounts of erosion of the aortic root or the free wall of the atrium associated with the worldwide use of the GORE ® HELEX ® Septal Occluder. The positive data comes from more than a decade of clinical experience using the Gore Device. This is encouraging news for the thousands of patients treated with the GORE ® HELEX ® Septal Occluder to close the genetic condition of atrial septal defect (ASD), an abnormal hole in the wall between the heart’s upper chambers. Leading cardiologists with experience using the Gore Device credit these outcomes with expanded polytetrafluorethylene (ePTFE) material, a biocompatible material that allows tissue ingrowth to seal the defect. “I have now used the GORE ® HELEX ® Device in more than 250 patients with excellent results. The complication rate is low and the closure rate is high,” said Ziyad M. Hijazi, MD, Course Director, PICS; Director, Rush Center for Congenital and Structural Heart Disease, Professor of Pediatrics and Internal Medicine, and Section Chief Pediatric Cardiology at Rush University Medical Center in Chicago. “When treating an ASD, if the Gore Device is appropriate, I will use it right away as the material is very soft and conforms to the shape of the hole. The GORE-TEX ® material is key.” “The GORE ® HELEX ® Septal Occluder is a device made mostly of GORE-TEX ® patch and minimal metal frame. It poses a low risk of thrombus formation on the disc, atrial arrhythmia complications from the device, and no reported cases of injury to the heart wall resulting in perforation, a potentially life-threatening complication,” stated John F. Rhodes, MD, Associate Professor in Pediatrics and Medicine at Duke University, Chief of the Children’s Heart Center, and Director of the Pediatric and Adult Congenital Cardiac Catheterization Laboratory in Durham, North Carolina. According to Thomas Forbes, MD, Director, Cardiac Catheterization Laboratory at Children’s Hospital of Michigan in Detroit; and Assistant Professor of Pediatrics at Wayne State University in Detroit, “There is no question that the GORE ® HELEX ® material is more conformable to the atria. The material’s mid and long term closure performance has been proven. I have treated hundreds of patients with the Gore Device and they have done extremely well. Overall, I am very happy with the experience.” The GORE ® HELEX ® Septal Occluder is a permanently implanted prosthesis and catheter delivery system, with deployment via standard femoral venous access. First cleared for use in Europe in 1999 and approved by the FDA in 2006, the occluder is composed of ePTFE material supported by a single nitinol wire frame. Over the course of several weeks to months following implantation of the device, cells begin to infiltrate and grow over the ePTFE material, aiding in the successful closure of the defect. “When treating an ASD, if the Gore Device is appropriate, I will use it right away as the material is very soft and conforms to the shape of the hole. The GORE-TEX ® material is key.” – Ziyad M. Hijazi, MD “Gore is committed to long term performance and quality in ensuring positive patient outcomes,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. “Material matters, and we are pleased that the data regarding our signature ePTFE material in the unique GORE ® HELEX ® Septal Occluder proves it.”
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