Kalamazoo-based medical technology company Stryker Corp. today announced the U.S. Food and Drug Administration has approved the Neuroform Atlas Stent System for marketing under a humanitarian device exemption (HDE). The device is to be utilized in conjunction with neurovascular embolic coils for the treatment of wide neck, intracranial, saccular aneurysms and allows the company to begin U.S. commercialization efforts immediately.
“The hybrid cell stent design of Neuroform Atlas is designed to improve wall apposition, ease of use, deployment accuracy, and catheter re-entry in even the most challenging cases,” says Dr. Osama O. Zaidat, director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio and co-principal Investigator of the U.S. Neuroform Atlas investigational trial. “The Atlas design may improve patient care by facilitating the treatment of wide neck aneurysms in tortuous and more complex anatomies.”
Stryker’s Neuroform Atlas is a small nitinol stent used in conjunction with metal coils to pack weakened blood vessel sacs in the brain called aneurysms. Neuroform Atlas is positioned through a small tube and delivered across the neck of the aneurysm to provide support and pack the blood vessel.
An estimated six million people nationwide have an unruptured brain aneurysm, approximately 25,000 of which are treated with endovascular or surgical treatments each year. Wide neck aneurysms, which Neuroform Atlas can treat, represent less than 10 percent of unruptured aneurysms treated.
Stryker completed enrollment of the anterior arm of the Neuroform Atlas clinical trial earlier this year, while enrollment continues for the posterior arm. The trial represents the largest data set on adjunctive stent use with intracranial aneurysm coiling.