Gore wins CE mark for AAA graft extensions
W. L. Gore & Associates won a CE mark for extensions of its Excluder-brand endovascular stent-graft to treat abdominal aortic aneurysms, enabling the company to reach a broader group of patients.
The latest Excluder now has 35 mm trunk-ipsilateral leg and 36 mm aortic extender components approved for use in the EU. They're meant to be used for patients with an infrarenal aortic inner neck diameter range between 30 mm and 32 mm, the company notes. Gore, as a result, can treat a larger number of patients, with a total treatment range of 19 mm to 32 mm.
Gore's Excluder, known as an AAA endoprosthesis, is delivered via catheter through a small incision in a patient's leg; it's an endovascular stent graft designed to both block off the aneurysm itself and open a new channel for blood flow, the company explains. The device is widely distributed around the globe. The more artery sizes it can work with, naturally, will help Gore both hold onto, and boost, its market share in the space.
Gore has also made some regulatory headway in the U.S. in recent weeks. Last month, Gore gained final U.S. regulatory approval to add the company's next-generation Septal Occluder to its REDUCE clinical study, which also includes Gore's Helex Septal Occluder. Both are being tested to treat patients who have a hole in the heart that heightens the risk for strokes.
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