Stryker announced that it has received US Food and Drug Administration (FDA) approval for an expanded indication of its Neuroform Atlas stent system as an adjunctive stent for use in the posterior circulation of the neurovasculature. In May 2019, the device was approved for use in the anterior circulation.
According to the company, the approval makes more feasible the long-term treatment of aneurysms in the posterior circulation, which rupture more frequently and are generally more difficult to treat.
Stryker advised that the Neuroform Atlas is a self-expanding nitinol stent indicated for use with neurovascular embolisation coils in the anterior and posterior circulation of the neurovasculature for the endovascular treatment of patients ≥18 years of age with saccular wide-necked (neck width ≥4mm or a dome-to-neck ratio of <2) intracranial aneurysms arising from a parent vessel with a diameter of ≥2 and ≤4.5mm. The stent is positioned across the aneurysm neck to hold metal coils in place and occlude the aneurysm.
The premarket approval (PMA) application for the expanded indication was granted based on clinical trial evidence proving the safety and efficacy of the device. The trial’s anterior and posterior cohorts were composed of a total of 298 patients.
Sam Zaidat, director of the Neuroscience and Stroke Center at Mercy Health System in Toledo, USA, is a co-principal investigator of the US Neuroform Atlas investigational device exemption trial.
“The Atlas posterior PMA trial data shows a compelling advancement in the treatment of wide-neck posterior aneurysms,” commented Zaidat in the company’s announcement. “Posterior stent-assisted coiling with Neuroform Atlas achieved an impressive high rate of complete occlusion in this very challenging location at 76.7%. Equally impressive was the 4.3% primary safety rate.”
Co-principal investigator Brian Jankowitz, who is director of Cerebrovascular Surgery at the Cooper Neurological Institute in Camden, USA, added, “Complete occlusion, or complete blocking of blood flow, is the gold standard in determining long-term aneurysm healing. With the additional challenges that come with treating posterior circulation aneurysms, we never would have anticipated reaching occlusion rates that rival those found in the anterior circulation. Now with Neuroform Atlas, those same high rates are achievable.”
