Stryker secures FDA PMA for Neuroform Atlas brain aneurysm stent system.

Stryker announced that it has secured FDA premarket approval for its Neuroform Atlas stent system intended for use in treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. Stryker previously received a humanitarian device exemption for the stent system that allowed for its use at specific hospitals with Institutional Review Board approval.

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..

�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.

Comment: An estimated six million people in the United States have an unruptured brain aneurysm, but only 25,000 receive endovascular or surgical treatment each year, according to statistics from the Brain Aneurysm Foundation. Wide-neck aneurysms, which are especially challenging to treat, represent less than 10% of unruptured aneurysms treated.