W.L. Gore & Associates won CE Mark approval for its new large Gore Excluder abdominal aortic aneurysms endoprosthesis, which could help physicians to treat AAA patients with an infrarenal aortic inner neck diameter in a range between 19-32 mm.
The device is an endovascular stent-graft, designed to be inserted through a small incision in the patient’s leg to seal off an aneurysm and create a new path for blood flow, according to the company.
"By expanding our sizing options to include larger anatomies, Gore now offers a complete range of sizes to treat differing anatomies with the preferred infrarenal placement, " Gore aortic business leader Ryan Takeuchi said in prepared remarks. "Gore strives to provide superior performance through design. Our extended AAA sizing portfolio and innovative delivery solution simplifies the Evar procedure for physicians and patients alike."
The Excluder AAA endoprosthesis, which features large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components, features one of the lowest profiles among devices of its kind, treating infrarenal aortic necks up to 32 mm in diameter, the company said.
The device, of which more than 135,000 have been distributed worldwide, is made by endovascular aneurysm repair physicians and Gore engineers, according to a press release.
Gore in October won FDA approval to add its next-generation GORE Septal Occluder to its Reduce clinical study, which is already evaluating its older Helex septal occluder in prevention of recurrent stroke in patients with patent foramen ovale, a hole between the upper chambers of the heart.