FDA Approves Neuroform Stent System for Posterior Aneurysms

Osama Zaidat, MD

Stryker has announced that the FDA has approved an expanded indication for its Neuroform Atlas Stent System, becoming the first and only adjunctive stent approved for treatment of aneurysms in the posterior circulation.¹

The expanded indication was granted based on evidence from the ATLAS Posterior PMA trial that included a total of 298 patients from both the anterior and posterior cohorts, demonstrating the safety and efficacy of the device in the largest recorded study of its kind.

"The ATLAS Posterior PMA trial data shows a compelling advancement in the treatment of wide-neck posterior aneurysms," Osama Zaidat, MD, director, Neuroscience and Stroke Center at Mercy Health System in Toledo, Ohio, and co-principal investigator of the US Neuroform Atlas investigational trial, said in a statement. "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."

The Neuroform Atlas Stent System operates as a self-expanding nitinol stent used in conjunction with metal coils to pack aneurysms within the brain. The stent is positioned across the aneurysm neck to hold metal coils in place and occlude the aneurysm.

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The FDA previously granted premarket approval to the Neuroform Atlas Stent System for the treatment of wide-neck, intracranial aneurysms in the anterior circulation in conjunction with embolic detachable coils in patients ≥18 years of age in May 2019. Findings from the ATLAS Investigational Device Exemption (IDC) trial were the basis of the approval.²

ATLAS was a prospective, multi-center, single arm study that included 30 subjects who completed clinical and imaging follow-up at 6 months and 27 of 30 participants who completed in-person 12-month clinical follow-up.

The primary end point, 12-month complete aneurysm angiographic occlusion without target aneurysm retreatment or significant parent artery stenosis at the target location, was observed in 26 of 30 participants (86.7%; 95% CI, 69.3%—96.2%) at 6 months and 25 of 27 (92.6%; 95% CI, 75.7%—99.1%) participants who completed the 12-month angiographic follow-up.³

The investigators noted that there were no unanticipated adverse events (AEs) from the study, but there were 3 events adjudicated by the Clinical Events Committee (CEC) as major (n = 1) or minor stroke (n = 2). The most frequently reported procedure-related adverse effects occurred in 12 subjects (40%) and were categorized as nervous system disorders (n = 20).

"Complete occlusion, or complete blocking of blood flow, is the gold standard in determining long term aneurysm healing," Brian Jankowitz, MD, director, cerebrovascular surgery at the Cooper Neurological Institute, said in a statement. "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."

REFERENCES

1. Stryker’s Neuroform Atlas Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain. News release.Stryker. August 3, 2020. Accessed August 3, 2020. https://www.biospace.com/article/releases/stryker-s-neuroform-atlas-stent-system-granted-an-expanded-indication-providing-a-new-option-for-patients-with-aneurysms-in-the-back-of-the-brain/

2. Stryker receives FDA premarket approval for the Neuroform Atlas® Stent System to treat brain aneurysms. News release. Stryker. May 20, 2019. Accessed August 3, 2020. https://www.prnmedia.prnewswire.com/news-releases/stryker-receives-fda-premarket-approval-for-the-neuroform-atlas-stent-system-to-treat-brain-aneurysms-300852724.html

3. Jankowitz J, Hanel R, Jadhav A, et al. Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort. J Neurointerv Surg. 2019;11(8):801-806. doi: 10.1136/neurintsurg-2018-014455