FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Endologix’ CE Mark for Aneurysm Sealing Device Gets Reinstated

June 10, 2019
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The CE Mark for Endologix’ Nellix system, an endovascular aneurysm sealing system, has been reinstated by an EU notified body following analysis of clinical evidence. The system lost its CE Mark following concerns over sub-optimal responses from patients.

The device, used for treating patients with infra-renal abdominal aortic aneurysms or aortoiliac aneurysms, will be used at approved centers in a post-market clinical investigation outside the U.S.

“This therapy continues to generate positive results when used in patients that conform to the anatomical indications for use. We are delighted that the available data supports the reinstatement of our CE mark,” said Matt Thompson, chief medical officer of Endologix.

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