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# Stryker Neuroform Atlas Stent System Approved
- URL: https://www.fdaweb.com/stryker-neuroform-atlas-stent-system-approved/
- Published: 2019-05-20T12:00:00.000Z
- Updated: 2026-09-15T01:27:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144142

FDA has approved a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. Approval was based on clinical trial data that showed an “84.7% primary efficacy rate, a 4.4% primary safety rate and a 3.8% retreatment rate.”

The self-expanding nitinol stent is intended to be used in conjunction with metal coils to pack weakened blood vessel sacs within the brain, the company says. It is positioned across the aneurysm neck to hold metal coils and occlude the aneurysm.