The Endograft Active Fixation The only device incorporating infrarenal anchors for active fixation with proven migration prevention through 5 years of follow-up.* Flexibility The deployment catheter is one of the most flexible catheter delivery systems available. Low Profile The only 18 Fr and 12 Fr delivery systems available in the U.S. * Annual Clinical Update, February 2006
The System The GORE SIM-PULL Deployment System Easy and Accurate Deployment The Only One-Step Deployment System Available Non-sheathed, one-step method to quickly and precisely deploy the stent-graft Integrated deployment knob allows for rapid device deployment while maintaining precise placement
The Data Long-Term 5-year Site Reported Results U.S. Pivotal Trial (n = 235)* 0 ruptures 1 post-procedure migration 1 stent fracture 0 graft tears 0 post-operative limb disconnections 0 deployment failures 10% total endoleak rate** (0% Type I, 8% Type II, 0% Type III and IV, and 2% indeterminate) 100% cumulative patency Low post-procedure conversion rate of 4.3% * Site Reported Data Through October 3, 2005 ** At 5 years
The Reputation Over 30,000 GORE EXCLUDER AAA Endoprostheses implanted* Over 13 million eptfe implants worldwide Over thirty years of experience in medical device implants * Through October 3, 2005
2003 October 2003. Gore adds 9 additional contralateral leg configurations to the EXCLUDER Product family. 2002 November 2002. Gore receives FDA approval for the EXCLUDER AAA Endoprosthesis. 2004 June 2004. Gore integrates a new low permeability material into the EXCLUDER Device design. 2005 November 2005. Gore adds 6 trunk-ipsilateral 12 cm configurations. Gore introduces 3 additional 14 cm trunkipsilateral configurations. The Evolution The Low Permeability GORE EXCLUDER AAA Endoprosthesis The latest device is engineered with a low permeability material. This material reduces the potential for serous fluid movement through the graft wall. Sutureless bonding and all of the other innovative features that distinguish the GORE EXCLUDER AAA Endoprosthesis from other devices remain the same. Original EXCLUDER Device Low Permeability Design EXCLUDER Device *This test measured transudate collected after forcing bovine serum through the graft wall under pressure. The graft was soaked in alcohol prior to the test to facilitate the transport of serum across the eptfe graft wall. W. L. Gore & Associates, Inc. Flagstaff, AZ 86004 800.437.8181 928.779.2771 (US) For international contact and additional product information, visit goremedical.com Indications for Use: Trunk-Ipsilateral Leg Endoprosthesis and Contralateral Leg Endoprosthesis Components. The GORE EXCLUDER Bifurcated Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: adequate iliac/femoral access, infrarenal aortic neck treatment diameter range of 19-26 mm and a minimum aortic neck length of 15 mm, proximal aortic neck angulation 60, iliac artery treatment diameter range of 8-18.5 mm and iliac distal vessel seal zone length of at least 10 mm. Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components. The GORE EXCLUDER Extender Endoprostheses (Aortic and Iliac) are intended to be used after deployment of the GORE EXCLUDER Bifurcated Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired. Contraindications: There are no known contraindications for these devices. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events. GORE, EXCLUDER, SIM-PULL, and designs are trademarks of W. L. Gore & Associates. 2006 W. L. Gore & Associates, Inc. AJ0041-EN2 MAY 2006