Michael Barbella, Managing Editor06.08.23
Amber Implants has obtained regulatory approval in Europe for a clinical study of its VCFix Spinal System. The approval allows the company to begin treating the first patients with the VCFix System, aiming to showcase the device's clinical safety and functionality.
"We are thrilled to embark on this study which will allow us to push the boundaries of medical innovation and pave the way for a brighter future in the field of spinal healthcare," an official company statement read.
The VCFix Spinal System is the first solution designed to treat a broad range of vertebral compression fractures (VCFs) without bone cement. With its unique design, the VCFix implant can potentially stimulate bone ingrowth, providing a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. The VCFix implant provides pedicle anchorage for better stability, better distribution of loads in the middle and posterior columns of the spine, as well the possibility for posterior fixation for more unstable fractures, according to Amber Implants. The VCFix Spinal System also includes a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection. VCFix aims to provide an easier, more efficient and safer solution for patients with vertebral fractures.
Amber Implants is a medical technology startup located in the Netherlands and United States. Founded in 2018, the company has developed VCFix Spinal System as the next generation of treatments for vertebral compression fractures, and is focused on improving patient outcomes through implants that provide more natural healing and stability. Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders in future.
"We are thrilled to embark on this study which will allow us to push the boundaries of medical innovation and pave the way for a brighter future in the field of spinal healthcare," an official company statement read.
The VCFix Spinal System is the first solution designed to treat a broad range of vertebral compression fractures (VCFs) without bone cement. With its unique design, the VCFix implant can potentially stimulate bone ingrowth, providing a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. The VCFix implant provides pedicle anchorage for better stability, better distribution of loads in the middle and posterior columns of the spine, as well the possibility for posterior fixation for more unstable fractures, according to Amber Implants. The VCFix Spinal System also includes a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection. VCFix aims to provide an easier, more efficient and safer solution for patients with vertebral fractures.
Amber Implants is a medical technology startup located in the Netherlands and United States. Founded in 2018, the company has developed VCFix Spinal System as the next generation of treatments for vertebral compression fractures, and is focused on improving patient outcomes through implants that provide more natural healing and stability. Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders in future.