For over 25 years, Gore & Associates (Gore) has been recognized as the leading provider of innovative expanded polytetrafluoroethylene (ePTFE) solutions for complex vascular problems. Gore's commitment to product quality and reliability is evidenced by over 10 million clinical implants of Gore Medical Products around the world.
In the late 1990s, Gore developed a thoracic endoprosthesis that would revolutionize the treatment of disease in the descending thoracic aorta and provide an effective alternative to traditional open surgery. Combining the company's expertise in ePTFE grafts and catheter-based delivery systems, Gore's thoracic endoprosthesis offered new hope for patients suffering from severe thoracic aortic diseases.
In November 2001, Gore voluntarily suspended worldwide sales of its thoracic endoprosthesis due to a stent fracture incidence rate that was deemed unacceptable by the company (the product remained available for re-intervention of previous Gore thoracic patients). "The decision to voluntarily suspend worldwide sales was a very difficult one," says Randy Chan, Gore Product Specialist. "Many physicians continued to regard Gore's thoracic endoprosthesis as a revolutionary breakthrough for the treatment of thoracic disease despite these stent fractures."
The Wait is Over
Following two years of intensive engineering and redesign efforts, Gore has announced the release of the new modified thoracic endoprosthesis. The GORE TAG Thoracic Endoprosthesis offers the same advanced features as the original design, but with greater durability. Gore has devoted considerable resources and attention to improving the long-term durability of the endoprosthesis through countless iterations of the design and subjecting the re-engineered device to the most rigorous motion and performance tests. The design enhancements, involving the removal of the longitudinal support wire and strengthening of the graft, ensure a lower risk of stent wire fractures and subsequent potential graft disruptions.
The GORE TAG Thoracic Endoprosthesis was designed to offer the utmost durability, flexibility and ease-of-use. The endoprosthesis features a flexible, maneuverable, low profile design that allows access to the most tortuous anatomies including the aortic arch. According to Dr. Michael Dake, Stanford University Medical Center, "As with the previous design, the GORE TAG Thoracic Endoprosthesis incorporates the ease-of-use and a wide size offering that allows treatment of the simplest to the most challenging aortic anatomies with minimal number of devices and low risk of procedural complications."
According to John Sininger, Leader of the Gore Medical Products Division, "This is an exciting time for Gore with the reintroduction of this life-saving technology. Our commitment to treatment of thoracic disease remains a top priority within the entire Gore corporation and we look forward to being leaders in this therapy now and in the future."
The GORE TAG Thoracic Endoprosthesis has obtained CE mark in Europe and will be available in several other countries pending regulatory approval. In the US, the product is currently undergoing a clinical evaluation (Investigational device. Limited by United States law to investigational use).
GORE and TAG are trademarks of W. L. Gore & Associates.
©2004 W. L. Gore & Associates. AG5122-EN2
W. L. Gore
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