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W. L. Gore & Associates Presents New Data and Clinical Updates at Transcatheter Cardiovascular Therapeutics (TCT) Conference 2008


Gore Continues Commitment to Clinical Research with Symposia, Ongoing Clinical Studies and Emerging Technologies

Flagstaff, AZ (October 8, 2008)—W. L. Gore & Associates (Gore) today announced it will have a major presence at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, October 12–17, 2008, at the Washington Conference Center in Washington, D.C. Continuing a 50-year tradition of innovation and commitment to research, Gore will host multiple forums during the conference that will provide cardiovascular interventionalists with the opportunity to share their clinical experiences, discuss new data, and learn about emerging technologies.

Planned symposia include a discussion on experiences using the GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface in the treatment of superficial femoral artery (SFA) disease. TCT attendees will also have the opportunity to engage in a presentation led by David Williams, RN, MSN, Gore Medical Clinical Leader, and discussion about Gore's commitment to the interventional cardiology community.

"At Gore, it is our responsibility to support clinical research that not only leads to the development of innovative treatments and therapies, but also deepens the scientific community's collective understanding of the medical conditions that we are helping to treat," said John Sininger, Medical Products Division Leader for Gore. "Collaboration between researchers and practitioners, as a means to better understand and utilize current medical treatments and inspire future therapies, has always been one of Gore's guiding principles."

During a TCT reception highlighting Gore's dedication to clinical research, Gore will recognize principal investigators from six different Gore clinical trials and studies currently underway. Principal investigators attending the reception include:

  • Gary Ansel, MD, Riverside Methodist Hospital Columbus, Ohio, principal investigator for the Gore VIBRANT Clinical Study; a randomized, prospective, multi-center clinical trial intended to demonstrate patency superiority in the treatment of lesions 8 cm or longer with the GORE VIABAHN Endoprosthesis compared to bare nitinol stents.
  • John Rhodes, MD, Duke University, Durham, North Carolina,  principal investigator for the Gore REDUCE Clinical Study, which is examining the use of the GORE HELEX Septal Occluder in PFO closure for the prevention of stroke.
  • Thomas Vesely, MD, Vascular Access Services, LLC., St. Louis, Missouri, principal investigator for the Gore REVISE Clinical Study, a randomized, multi-center trial in the US intended to establish efficacy and safety of the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous (AV) grafts at the venous anastomosis in hemodialysis patients.
  • Tanvir Bajwa, MD, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, principal investigator for the Gore VIPER Patient Registry, a prospective, single-arm, multi-center evaluation of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface that will collect important performance data of the device.
  • Daniel Clair, MD, Cleveland Clinic Foundation, Cleveland, Ohio, and L. Nelson Hopkins, MD, University of Buffalo Neurosurgery, Buffalo, New York, principal investigators for the Gore EMPiRE Clinical Study, designed to demonstrate the safety and efficacy of the GORE Flow Reversal System when used for embolic protection during Carotid Artery Stenting (CAS) procedures.
  • William Gray, MD, Columbia University Medical Center, New York, New York, principal investigator for the Gore EMBOLDEN Clinical Study, which compares the 30-day safety and efficacy of the GORE Embolic Filter when used in conjunction with FDA-approved carotid stents to carotid stent studies utilizing distal embolic protection.

Additionally, Patrick Peeters, MD, from Imelda Hospital in Belgium, will present four-year follow-up data of a prospective, multi-center study of the GORE PROPATEN® Vascular Graft in lower limb bypass.

As a result of Gore's dedication to clinical research, the company is pleased to announce full investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) to proceed with the Gore EMBOLDEN Clinical Study*, a prospective, multi-center, non-randomized, single-arm study. It compares the 30-day safety and efficacy of the GORE Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.

About W. L. Gore & Associates

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 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 materials 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 11th consecutive year. For more information, visit goremedical.com

Contact

Shannon Murphy or Courtney Smith
Schwartz Communications, Inc. for W. L. Gore & Associates
415-512-0770 or 781-684-0770
GoreMedical@schwartz-pr.com

*CAUTION: Investigational device, limited by federal (or United States) law to investigational use.

Products listed may not be available in all markets pending regulatory clearance. GORE, HELEX, PROPATEN, and VIABAHN® are trademarks of W. L. Gore & Associates.