The FDA has issued Stryker with approval for the company’s Neuroform Atlas Stent System. It is indicated for treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils, so far only the second stent approved for such procedures.
The nitinol Neuroform Atlas stent is used to hold tiny metal coils inside an aneurysm, working together with the coils at preventing further expansion of the aneurysm.
The device was previously only available at select hospitals through the humanitarian device exemption, and the latest approval was in part based on the use of the Neuroform Atlas at these facilities. “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,” in a published statement said Dr. Osama O. Zaidat, 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. “More impressive were the results with an 84.7% primary efficacy rate, a 4.4% primary safety rate and a 3.8% retreatment rate.”
“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,” added Dr. Brian Jankowitz, Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center and Co-Principal Investigator of the study. “This product is changing my clinical practice by allowing more patients with difficult aneurysms an option at endovascular treatment while improving the quality and safety of treatment.”
Product page: Neuroform Atlas…
Via: Stryker…