FDA gives HDE approval for Neuroform Atlas to treat wide neck aneurysms

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Neuroform Atlas

The US Food and Drug Administration has approved the Neuroform Atlas Stent System (Stryker) for marketing under a humanitarian device exemption (HDE). The device is to be utilised in conjunction with neurovascular embolic coils for the treatment of wide neck, saccular intracranial aneurysms and allows the company to begin US commercialisation 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 Osama O Zaidat, director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, USA, and co-principal investigator of the US 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 US market is a significant advantage to physicians,” says 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.”

The Humanitarian Device Exemption means that Neuroform Atlas is authorised by federal law for use with neurovascular embolic coils in patients who are ≥18 years of age for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥2mm and ≤4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ≥4mm or a dome-to-neck ratio <2. The effectiveness of this device for this use has not been demonstrated.

Stryker completed enrolment of the anterior arm of the Neuroform Atlas US IDE clinical trial earlier this year while enrolment continues for the posterior arm. This important trial represents the largest data set on adjunctive stent use with intracranial aneurysm coiling.

 

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