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 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,” trial co-principal investigator Dr. Osama Zaidat of Toledo, Ohio’s Mercy Hospital said in prepared remarks.

“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,” study co-principal invetsigator Dr. Brian Jankowitz of the University of Pittsburgh Medical Center said in a prepared statement.

Late last month, Stryker said that its Performance Solutions division launched the Practice Excellence program designed to help orthopedic practices improve profitability, efficiency and quality outcomes.

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