Amber Implants wins FDA clearance for VCFix spinal system

Amber Implants today announced it received FDA 510(k) clearance for its VCFix Spinal System.

The Netherlands-based company designed VCFix to treat vertebral compression fractures. The system is a minimally invasive vertebral augmentation device used with bone cement. It provides support to both the anterior and posterior spinal columns and is intended to improve stabilization while reducing patient risk and shortening procedure times.

One-year follow-up data from initial clinical trials, announced in June, showed sustained pain reduction, improved stability and faster recovery. The company said it is also pursuing CE mark in the European Union.

See full article (https://www.massdevice.com/amber-implants-wins-fda-clearance-for-vcfix-spinal-system/)