W. L. Gore & Associates recently announced the first human implants of their next generation Conformable GORE TAG® Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms(TAAs). The devices were used to treat patients with a TAA, which is an enlargement that develops in weakened areas of the thoracic aorta.
Gore received approval of an investigational device exemption (IDE) from the USFDA.
The commercially available device provides a minimally invasive option and is comprised of an ePTFE graft with an outer self-expanding nitinol support structure that looks to combine device flexibility and material durability. It received pre-market approval from the FDA in 2005.
In addition to TAAs, the next generation product has been approved to investigate endovascular repair of other etiologies including traumatic aortic transection and aortic dissection. Design enhancements include a modified stent frame, repositioned gold bands and optimized graft material.
Thoracic aneurysms affect approximately 15,000 people in the United States each year. Some patients may have more than one TAA or may also have an aneurysm in the abdominal aorta. Only about 20 to 30 percent of patients who get to the hospital with a ruptured TAA survive. For this reason, it is crucial to treat aneurysms early in order to prevent their rupture.