Stryker Receives FDA HDE Approval For The Neuroform Atlas Stent System

Stryker Corporation announced that the FDA 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.”

“The ability to navigate distal anatomy within the brain using the lowest profile delivery on the U.S. market is a significant advantage to physicians,” says Dr. Brian Jankowitz, Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center and Co-Principal Investigator of the study.  “Atlas opens up treatment options for a new segment of patients that would otherwise have been considered too risky to treat.”

Mark Paul, president of Stryker’s Neurovascular division, adds, “The Neuroform Atlas Stent System is the most recent addition to Stryker’s innovative product portfolio, providing a continuum of complete stroke care for patients suffering from cerebrovascular disease. With Neuroform Atlas commercially available in 46 countries, patients around the world are now benefiting from significant advancements in intracranial stents designed specifically for the treatment of wide neck aneurysms.  This product is an excellent fit with our mission to make healthcare better.”