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Medical Devices / Submissions and Approvals

Stryker Grabs PMA for Aneurysm Adjunctive Stent

May 22, 2019
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The FDA has granted Stryker premarket approval for its Neuroform Atlas aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms.

The self-expanding nitinol stent is approved for use alongside metal coils to pack weakened blood vessels in the brain. It received prior approval under a humanitarian device exemption, confining its use to approved hospitals.

The stent features improved conformability and a “low-profile” delivery system that assists in the treatment of difficult aneurysms.

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