Stryker receives US FDA HDE approval for Neuroform Atlas Stent System

U.S. Food medical technology company, Stryker Corporation has announced that 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. 

Stryker’s Neuroform Atlas is a small nitinol stent that is 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 aneurysm.

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 said, "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. The Atlas design may improve patient care by facilitating the treatment of wide neck aneurysms in tortuous and more complex anatomies."

Dr. Brian Jankowitz, Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center and Co-Principal Investigator of the study said, "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. 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, added, "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."