Arizona medical device maker W.L. Gore & Assoc. announced CE Mark approval in the European Union for new components of its Gore Excluder AAA endoprosthesis in treatment of abdominal aortic aneurysms.
European regulators cleared Gore’s lower-profile 31 mm diameter ipsilateral leg and 32 mm aortic extender, designed for use with the Excluder AAA stent-graft in sealing off aneurysms and creating new paths for blood flow.
The new components make the catheter-based Excluder AAA one of the lowest-profile devices available for treating aortic necks with an inner diameter in the range of 27-29 mm, according to a press release.
Gore isn’t making any changes to the Excluder AAA device itself, but instead developed a method of constraining the device onto the catheter. The company plans to roll out new lower-profile Excluder devices in the future.
Late last year Gore won CE Mark for its larger next-generation Excluder AAA endoprosthesis, featuring large diameter 35 mm trunk-ipsilateral legs and 36 mm aortic extender components.
