The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Stryker’s Neuroform Atlas Stent System for the treatment of brain aneurysms.
The second aneurysm adjunctive stent is indicated for wide-neck, intracranial aneurysms in combination with embolic detachable coils to pack weakened blood vessel sacs in the brain.
A self-expanding nitinol stent, Neuroform Atlas can be positioned across the aneurysm neck to hold metal coils and occlude the aneurysm.
Previously, the device was granted humanitarian device exemption, allowing its use in specific hospitals. The latest PMA approval is based on the efficacy data obtained during clinical trials of the stent system.
Stryker Neurovascular division president Mark Paul said: “Meaningful clinical data enables our market-leading products to better serve patients suffering from debilitating cerebrovascular disease.
“PMA approval of Neuroform Atlas Stent System is a significant milestone in providing world-class technology to our physicians.”
US Neuroform Atlas investigational trial principal investigator Osama Zaidat noted that the stent system showed an 84.7% primary efficacy rate, 4.4% primary safety rate and 3.8% retreatment rate.
Study co-principal investigator Brian Jankowitz added: “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.”
The stent system can be used with neurovascular embolization coils in the anterior circulation of the neurovasculature for endovascular treatment.
It is meant for patients aged 18 years or over suffering from saccular wide-necked intracranial aneurysms that arise from a parent vessel with a diameter of ≥ 2mm and ≤ 4.5mm.