W.L. Gore & Associates said it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare to market its Excluder AAA endoprosthesis with C3 delivery system for treatment of abdominal aortic aneurysms.
The Excluder is an endovascular stent-graft, which is commonly inserted through a small incision to seal off an aneurysm and create a new path for blood flow. The C3 delivery system allows for the delivery of the graft to be less invasive. In addition, the C3 allows for the repositioning of the Excluder before final delivery from the catheter, according to a press release.
“Since launching the Gore C3 Delivery System for the Gore Excluder device in 2011, it has shown a high level of performance, allowing physicians to achieve the best possible deployment of the stent-graft. Through our innovative designs and close collaboration with the endovascular community, Gore aims to bring safe and effective minimally invasive endovascular repair to patients worldwide,” Aortic business leader Ryan Takeuchi said in prepared remarks.
The Newark, Del.-based company began a 1st clinical trial for its Excluder iliac branch devices for treating patients with common iliac artery aneurysms. In addition, Gore won CE Mark approval in the European Union for its Excluder iliac branch stent graft.