Stryker wins FDA HDE nod or Neuroform Atlas wide-neck aneurysm stent

Stryker (NYSE:SYK) said today it won humanitarian device exemption from the FDA for its Neuroform Atlas stent system designed to be used with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms. The newly HDE-cleared Neuroform Atlas is a nitinol stent designed to be used with metal coils to pack aneurysms in the brain. The system is positioned through a small tube and delivered across the neck of the aneurysm to support and pack it, the company said. Wide neck aneurysms are estimated to represent less than 10% of unruptured aneurysms treated. “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,” Stryker neurovascular division prez Mark Paul said in a press release. Kalamazoo, Mich.-based Stryker said it has completed enrollment in the anterior arm of a Neuroform Atlas US IDE trial and is continuing to enroll for the posterior arm of the trial. “The hybrid cell stent design of Neuroform Atlas is designed to improve wall apposition, ease of use, deployment accuracy, and cathete...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Stents Vascular Stryker Source Type: news