Amber Implants VCFix Granted FDA Breakthrough Designation

By Julie A. Vetalice

Amber Implants VCFix Granted FDA Breakthrough Designation

Amber Implants was granted Breakthrough Device Designation by FDA for its VCFix® spinal system, which aims to improve the treatment of vertebral fractures.

A first-In-human clinical trial is expected to commence in early 2022 in Europe and the U.S.

VCFix spinal system is the first solution to treat vertebral fractures that does not rely on bone cement. Through its 3D-printed perforated structure, VCFix implant aims to stimulate bone ingrowth as a more natural healing process, while providing better stability and better distribution of loads in the spine. The promise of Amber Implants is to bring an easier, more efficient and safer treatment for a broader type of fractures to the market.

Source: Amber Implants

Product Labels: Spinal Fusion

Tags: Regulatory