Neuroform Atlas Stent System

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Intracranial coil-assist stent

PMA Number

P180031 ↗

FDA Product Code

QCA

Device Class

Class III

Advisory Committee

Neurology

FDA Decision

APPR Approved

• Wingspan

  Class III

  CE/MDR MDR 739951 Active Valid to May 2028

• AXS Catalyst 6

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• Trenza

  Class III

  CE/MDR MDR 829526 Active Valid to Jun 2031

• AXS Catalyst 5

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• AXS Catalyst 7

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• AXS Infinity LS

  Class III

  CE/MDR MDR 736166 Expiring Valid to Oct 2027

See all devices from Stryker Neurovascular →

• What types of intracranial aneurysms is the Neuroform Atlas® Stent System designed to assist with during embolization procedures?

  The Neuroform Atlas® Stent System is specifically designed to assist in the embolization of wide-necked intracranial aneurysms in the anterior circulation. It is intended for aneurysms with a neck width of 4 mm or greater, or a dome-to-neck ratio of less than 2, arising from parent vessels between 2.0 mm and 4.5 mm in diameter. This makes it suitable for complex cases where traditional coiling alone may be challenging.

• Is the Neuroform Atlas® Stent System intended for use in patients of all ages, or is there an age restriction?

  The Neuroform Atlas® Stent System is intended for use in patients aged 18 years and older. The device is not approved for pediatric or adolescent patients under the age of 18, as its design and regulatory approval are tailored to the adult neurovascular anatomy and clinical needs.

• How is the Neuroform Atlas® Stent System supplied, and what considerations should be made for its storage and handling?

  The Neuroform Atlas® Stent System is supplied as a sterile, single-use device, meaning it is intended for one-time use per procedure. Storage and handling must follow standard sterile medical device protocols to maintain its integrity. Since it is designed for neurovascular procedures, it should be stored in a controlled environment, protected from contamination, and used only in clinical settings equipped for endovascular treatments.

• What compatibility requirements exist for the Neuroform Atlas® Stent System with other medical devices during embolization?

  The Neuroform Atlas® Stent System is explicitly designed to be compatible with neurovascular embolization coils. This compatibility ensures that the stent can assist in the placement and stability of coils within the aneurysm during the embolization procedure, improving the likelihood of successful treatment for wide-necked aneurysms in the anterior circulation.

• What regulatory pathway was followed for the approval of the Neuroform Atlas® Stent System, and what does this mean for its use?

  The Neuroform Atlas® Stent System underwent a Premarket Approval (PMA) process through the FDA, which is the most stringent regulatory pathway for Class III medical devices. This approval indicates that the device has been thoroughly evaluated for safety and effectiveness in its intended use—assisting in the embolization of wide-necked intracranial aneurysms in the anterior circulation. Its use is restricted to qualified neurointerventionalists in clinical settings equipped for endovascular procedures, ensuring proper training and infrastructure are in place.