Stryker (NYSE:SYK) said today that it won FDA premarket approval for its Neuroform Atlas stent system intended for use in treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils.
The Neuroform Atlas stent system previously won approval from the FDA under a humanitarian device exemption which restricted its use to specific hospitals with institutional review board approval, the Kalamazoo, Mich.-based company said.
The Neuroform Atlas Stent system is a self-expanding nitinol stent intended for use in conjunction with metal coils to pack aneurysms within the brain, Stryker said. The stent is positioned across the aneurysm’s neck and and is designed to hold metal coils and occlude the aneurysm.
“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,” co-principal investigator of the U.S. Neuroform Atlas investigation trial Dr. Osama Zaidat of Toledo, Ohio’s Mercy Hospital said in a press release.
“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,” co-principal study investigator Dr. Brian Jankowitz of the University of Pittsburgh Medical Center said in prepared remarks.
Stryker said that the Neuroform Atlas stent is now indicated for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients 18 years or older with saccular wide-necked intracranial aneurysms arising from a parent vessel with a diameter of between 2 mm and 4.5 mm.
“Proving the safety and efficacy of our products through landmark clinical trials is a top priority and key differentiator for Stryker. 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,” neurovascular division prez Mark Paul said in a prepared statement.
Late last month, the FDA posted a safety communication warning that the off-label use of Stryker Wingspan stent system, designed to open narrowed arteries in the brain for patients with intracranial stenosis who experience repeated strokes, can increase the incidence of stroke or death.
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