September 27, 2016 3:48 AM ET

Chemicals

Company Overview of W. L. Gore & Associates, Inc.

Company Overview

W. L. Gore & Associates, Inc. manufactures electronics, fabrics, industrial, and medical products. It provides consumer products, including waterproof, windproof, and breathable garments, footwear and accessories, guitar strings, and vacuum cleaner bags; cables and cable assemblies; electronic and electrochemical materials, such as EMI shielding and grounding solutions, fuel cell components, and electrochemical device components; fabrics, including public safety, military, and fire and safety service fabrics; and fibers, such as sewing threads, weaving yarns, and rope fibers. The company also offers filtration products; medical products, including implantable medical devices and medical OEM ...

555 Papermill Road

Newark, DE 19711

United States

Founded in 1958

Phone:

410-506-7787

Fax:

410-506-7633

Key Executives for W. L. Gore & Associates, Inc.

Chief Executive Officer and President
Media Relations Manager
Compensation as of Fiscal Year 2016.

W. L. Gore & Associates, Inc. Key Developments

W. L. Gore & Associates, Inc. Announces Positive Results from A Prospective, Multicenter Investigational Device Exemption (IDE) Clinical Study of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in Japan

W. L. Gore & Associates, Inc. announced positive results from a prospective, multicenter Investigational Device Exemption (IDE) Clinical Study of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in Japan. The device demonstrated excellent outcomes in treating long, complex lesions in the superficial femoral artery (SFA), achieving 88% primary patency at 12 months. The prospective single-arm study enrolled 103 patients for analysis across 15 trial sites. The trial enrolled a challenging patient population with greater than 10cm long lesions, including 84.5% TASC II C/D lesions, and 65.7% of lesions having chronic total occlusions (CTO). The GORE VIABAHN Endoprosthesis showed favorable outcomes consistent with previous clinical studies. Primary patency at 12 months in all lesions (average of 21.8 cm) was 88%, while lesions less than or equal to 20 cm recorded 93% primary patency. The study also demonstrated 100% limb salvage with zero cases of acute limb ischemia (ALI), bypass or amputation. The GORE VIABAHN Endoprosthesis is backed by a growing body of clinical data proving its safety and efficacy in challenging, real-world SFA lesions. The Gore Japan IDE Clinical Study is now the fourth prospective, multicenter trial to study performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in complex de novo and restenotic SFA disease. When all figures and data from the research are combined, the 359 limbs studied in these four trials have an average lesion length of 21 cm with 71% CTO. The combined 12-month primary patency seen in the Gore VIPER Clinical Study, VIASTAR Trial, the GORE VIABAHN Device 25 cm Trial, and the Gore Japan IDE Clinical Study is 78%.

W. L. Gore & Associates, Inc. Announces the Commercial Availability of the GORE® DrySeal Flex Introducer Sheath

W. L. Gore & Associates, Inc. announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures. The 12 Fr x 45 cm sheath configuration is engineered specifically for use with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the only device indicated in the U.S. for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control. The new sheath leverages technology from Gore’s long-trusted GORE® DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45, and 65 cm. The GORE DrySeal Flex Introducer Sheath and IBE are available in the U.S., Europe, Canada, and Australia.

W. L. Gore & Associates, Inc.'s GORE® TIGRIS® Vascular Stent Gains FDA Approval for Treatment of Peripheral Artery Disease

W. L. Gore & Associates, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the GORE® TIGRIS® Vascular Stent, a dual-component stent with a unique fluoropolymer /nitinol design. The GORE TIGRIS device, which gained CE Mark approval in 2011, is a third generation, self-expanding stent. The device was designed explicitly to improve anatomical conformability with the natural movement of the knee when treating Peripheral Artery Disease (PAD). GORE® TIGRIS® Vascular Stent, a dual-component stent with a unique fluoropolymer /nitinol design the newly-approved GORE TIGRIS Vascular Stent uses a dual component structure, made from a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections. The stent has been designed to weather biomechanical forces (extension, compression, flexion and torsion) without fractures, even in the most complex anatomies, namely in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). In the U.S. clinical study that supported FDA approval of the GORE TIGRIS Vascular Stent, the TIGRIS stent was found to have zero fractures, while the control arm devices experienced a 27% fracture rate. The TIGRIS Vascular Stent has an innovative design that is very different from any of the other nitinol stents that currently use. The extreme flexibility of this stent makes it well suited for the superficial femoral artery and proximal popliteal artery, and the delivery system is highly accurate. The precision offered by this flexible, dual component device allows for easy insertion and predictable clinical outcomes, even in challenging anatomy. The new device builds on the company’s long history and experience with stenting, which spans more than two decades. The GORE TIGRIS Vascular Stent also features Gore's CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation, a problem common in both bare metal and drug-eluting stents. End-point covalent bonding keeps heparin anchored to the stent surface, while the bioactive site remains free to interact with the blood to help prevent clotting. The evolution of peripheral stenting over the past decade has allowed for broader adoption of endovascular therapy for treating PAD. When physicians began placing stents in the SFA they were limited by first generation stent designs that had longitudinal metal connections which led to arterial stiffening, high fracture rates and poorer clinical outcomes. Improvements in second generation devices introduced helical interconnections to improve flexibility; however, their success in high flexion vessels, like the distal SFA and PPA, was still limited. The introduction of third generation stents, including the GORE TIGRIS Vascular Stent, allow for better adherence in some of the more intricate vessels in the body. PAD is prevalent in older populations, a rapidly growing demographic in developed countries. In the U.S. alone, approximately 8 to 12 million people suffer from some form of PAD. The disease can manifest in mild symptoms such as chronic leg pain, and more serious complications include poor wound healing, increased risk of stroke, and amputation. Endovascular treatment, via angioplasty and stenting of a blocked artery, is designed to treat PAD without the complications that can accompany open surgery.

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