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# Breakthrough Status for Knee Arthritis Device
- URL: https://www.fdaweb.com/breakthrough-status-for-knee-arthritis-device/
- Published: 2025-02-11T12:00:00.000Z
- Updated: 2026-09-14T14:52:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158642

FDA has granted Guerbet a Breakthrough Device Designation for LipioJoint, a transient liquid embolic agent designed to alleviate pain in patients with knee osteoarthritis. The company says the device is being developed for Genicular Artery Embolization (GAE), a minimally invasive procedure performed by interventional radiologists. The product is intended to selectively embolize the knee synovial neovessels that are present in knee osteoarthritis, it says. The designation is based on clinical data from the Lipiojoint-1 study (NCT04733092) that demonstrated “promising outcomes in pain reduction and knee function,” Guerbet says.