Stryker (NYSE:SYK) recently announced its Neuroform Atlas Stent System received expanded indication from the FDA.
The Neuroform Atlas Stent System is now approved for use in the posterior circulation. With the approval, the company said long term treatment is more feasible with the device.
Prior to the new indication, the stent system was approved for use in the anterior circulation of the brain. Expanded indication was granted based on clinical trial evidence proving the safety and efficacy of the device.
“The Atlas Posterior PMA trial data shows a compelling advancement in the treatment of wide-neck posterior aneurysms,” Sam Zaidat, an investigator on the U.S. Neuroform Atlas investigational trial, said in a news release. “Posterior stent-assisted coiling with Neuroform Atlas achieved an impressively high rate of complete occlusion in this very challenging location at 76.7%. Equally impressive was the 4.3% primary safety rate.”
Stryker’s Neuroform Atlas Stent System is a self-expanding nitinol stent that is used in conjunction with metal coils to pack aneurysms within the brain. It is positioned across the aneurysm neck to hold metal coils in place and occlude the aneurysm. The system is indicated for use with neurovascular embolization coils in the anterior and posterior circulation of the neurovasculature to treat endovascular patients aged 18 years or older with saccular wide-necked intracranial aneurysms.
“The results from the Atlas Posterior PMA trial demonstrate that physicians can now address the more difficult posterior circulation aneurysms, offering hope for better outcomes in that patient population,” Mark Paul, president of Stryker’s neuromuscular division, said. “This expanded indication of Neuroform Atlas, as the first and only adjunctive stent for use in the posterior circulation, reflects our ongoing commitment to advancing stroke care for patients with cerebrovascular disease.”