Amber Implants receives FDA breakthrough device designation for spinal system
Amber Implants has announced FDA breakthrough device designation for the VCFix spinal system for treatment of vertebral fractures, according to a company press release.
The VCFix implant is a 3D-printed perforated structure designed to stimulate bone ingrowth for the treatment of vertebral fractures without bone cement, according to the release.
“Receiving U.S. FDA breakthrough designation is a tremendous recognition that will boost our efforts to bring VCFix to patients,” Banafsheh Sajadi, PhD, founder and CEO of Amber Implants, said in the release. “This development speeds up our timeline significantly, with our first in-human clinical trial expected to commence in early 2022 both in Europe and the U.S., taking us one step closer to improving the quality of life of patients with vertebral fractures.”
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