Stryker's Neuroform Atlas Stent System Approved by FDA to Treat Intracranial Aneurysms
May 20, 2019—Stryker announced FDA premarket approval of its Neuroform Atlas stent system for the treatment of wide-neck intracranial aneurysms in conjunction with embolic detachable coils. The Neuroform Atlas device was previously approved under a humanitarian device exemption, which restricted use to specific hospitals with institutional review board approval. Premarket approval was granted based on robust clinical trial evidence proving the efficacy of the device.
According to Stryker, Neuroform Atlas is a self-expanding nitinol stent. The device is indicated for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients aged ≥ 18 years with saccular wide-neck (neck width ≥ 4 mm or a dome-to-neck ratio < 2) intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4.5 mm.
Osama O. Zaidat, MD, who is Coprincipal Investigator of the Neuroform Atlas investigational device exemption (IDE) trial, commented in the company's announcement, "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. More impressive were the results, with an 84.7% primary efficacy rate, a 4.4% primary safety rate, and a 3.8% retreatment rate." Dr. Zaidat is Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio.
Additionally, the study's Coprincipal Investigator Brian Jankowitz, MD, stated, "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. 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." Dr. Jankowitz is Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.