Stryker Grabs PMA for Aneurysm Adjunctive Stent
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.