ArteryFlow Technology Receives FDA 510(K) Clearance for AneuGuide®

Recently, ArteryFlow Technology announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for AneuGuide®. The algorithm proposes appropriate dimension of flow diverters (FDs) and visualizes its deployment preoperatively, enabling physicians to select the optimal surgical plan. In the field of endovascular treatment for intracranial aneurysms (IAs), AneuGuide® serves as the 1st domestic FDA cleared medical tool. Meanwhile, it’s the 2nd FDA cleared medical tool developed by ArteryFlow Technology after AccuFFR®angio.

 

Today, FDs treatment is becoming more and more prevalent in endovascular treatment, especially for large and wide-necked IAs. However, the sizing of braided stents, e.g., the majority of FDs, has always been a thorny issue due to their complicated foreshortening behavior. AneuGuide® automatically reconstructs the 3D model of intracranial arteries based on imaging data from 3D rotational angiography (3DRA), and then calculates the geometry of the implanted stent virtually according the anticipated landing zone, thus providing a solution for fast and accurate sizing of braided stents.

Advantages of AneuGuide®:

  • Enable users to virtually ‘move’ the implanted stent in real time
  • Enable users to query apposition, metal coverage ratio and pore density
  • Enable users to compare two selections concurrently

 

Clinical benefits of AneuGuide®:

  • Lower the barrier for neurointerventionalists to master the sizing of FDs
  • Reduce the time of surgery and the radiation dose for both neurointerventionalists and patients