W. L. Gore & Associates (Gore) announced that it has received approval from the US Food and Drug Administration (FDA) to market a 31 mm diameter version of the GORE EXCLUDER® AAA Endoprosthesis. The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms (AAA) in patients with aortic inner neck diameters up to 29 mm. Other important enhancements include a flat-top design that enables greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation, and a lengthening of the trunk from seven to eight cm to accommodate larger anatomies.
More than 84,000 GORE EXCLUDER Devices have been implanted in patients worldwide, making it a widely accepted, minimally invasive treatment option for individuals with AAA. The 31 mm device will be available for clinical use in the US in May 2009. It has been available outside of the US since 2004 and has been implanted in more than 3,300 patients.
AAA involves swelling or bulging of the abdominal aorta. When the condition is not treated it can lead to aortic rupture, which is often fatal. Traditional surgical treatment requires a large incision to place a synthetic graft to repair the diseased artery. This method can result in long hospital stays and painful recoveries. The GORE EXCLUDER AAA Endoprosthesis, in contrast, uses a minimally invasive procedure, thereby reducing the hospital stay, morbidity and mortality associated with surgery.
The Gore device is an endovascular graft and stent combination that seals off the aneurysm and creates a new path for blood flow. The device is inserted through a small incision in the patient’s leg using a catheter-based delivery technique. Once the physician has positioned the graft in the diseased aorta, the device self-expands using radial force. Metal anchors help secure it to the walls of the aorta.
“The GORE EXCLUDER AAA Endoprosthesis is backed by more than 11 years of commercial data that consistently shows the superior performance of the device,” said David Abeyta, Aortic Business Unit Leader at Gore. “It has become a leading option for physicians in North America for the treatment of AAA. The unique design of the 31 mm device allows physicians to treat patients with a larger range of anatomies, and the fact that it can be implanted using a minimally invasive procedure means that most patients recover faster and more comfortably.”
The 31 mm GORE EXCLUDER Device will be available in 13, 15 and 17 cm lengths. A new 32 mm x 4.5 cm Aortic Extender Component will join the device family as well. Both the new Trunk-Ipsilateral Leg and Aortic Extender Components are 20 Fr introducer sheath compatible.
Source: W. L. Gore & Associates
published: March 31, 2009 in: Cardio, Companies, Products, Regulatory, Specialty, USA