FDA Clears Mobile C-Arm Device Designed for Complex Vascular Procedures

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Zenition 90 Motorized C-arm platform, a system that may provide improved visualization and efficiencies in workflow for complex procedures.

User-friendly controls at the table side and automated workflow advances promote greater efficiency and flexibility for clinicians utilizing the Zenition 90 Motorized C-arm system, according to Philips, the manufacturer of the system. The company noted that usability studies of the Zenition 90 Motorized C-arm system in simulated environments found that 97 percent of clinicians noted time savings with workflow features such as the Automatic Vascular Outlining.

While the Zenition 90 Motorized C-arm system was designed for use in complex vascular procedures, Philips said clinicians may also employ the imaging system in cardiac interventions, urology applications and pain management.

“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” said Mark Stoffels, the business leader for Philips Image Guided Therapy Systems. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.”

Philips said it will showcase the Zenition 90 Motorized C-arm system June 19-22 at the 2024 Society for Vascular Surgery Annual Meeting in Chicago.