Neuroform Atlas Stent System to Treat Brain Aneurysms with Embolic Coils is awarded FDA Approval

Neuroform Atlas Stent system developed by the company, Stryker has recently been granted FDA approval. The system designed by the company, so far is only the second stent to have received the approval for performing a procedure such as treating wide- neck, intracranial aneurysms in conjunction with embolic detachable coils.

To curb further expansion of the aneurysm, tiny metal coils are held by the nitinol Neuroform Atlas stent inside an aneurysm, working together with the coils.

Through the humanitarian device exemption, the device was previously only available at particular hospitals. The latest approval was in part based on the use of the Neuroform Atlas at these facilities. Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio, and Co-Principal Investigator of the U.S. Neuroform Atlas investigational trial, Dr. Osama O. Zaidat, gave a published statement sharing that Neuroform Atlas represents a significant advancement in the treatment of wide-neck aneurysms which is now backed by the largest IDE stent-coil trial completed to date. She shared the highly impressive results of the system which included a primary efficacy rate of 84.7%, a primary safety rate of 4.4% and a retreatment rate of 3.8%.

Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center and Co-Principal Investigator of the study, Dr. Brian Jankowitz, added by saying that enhanced stent conformability, a low-profile delivery system and high deployment accuracy even in distal anatomy puts Neuroform Atlas in a category of its own. Dr. Brian Jankowitz emphasized on the benefits of the system which is helping in changing his clinical practive altogether. The system provides an option at endovascular treatment while improving the quality and safety of treatment more patients with difficult aneurysms.

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