The Hague, Netherlands, October 5, 2021/PRNewswire/ – Amber Implants, an innovative medical technology company that develops next-generation spinal implants for spinal injuries, today announced that its VCFix® spinal system, which aims to improve the treatment of vertebral fractures, has been awarded Breakthrough device designation by the US FDA.
The US FDA’s breakthrough device program allows patients to obtain breakthrough technologies in a timely manner, which may provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This allows Amber Implants to communicate directly and interactively with the US FDA and priority review. Amber Implants will also have greater flexibility in clinical research, a dedicated team to review applications, and reimbursement through Medicare for 4 years.
PhD. Banavshe SajadiThe founder and CEO of Amber Implants said: “Obtaining a breakthrough designation by the US FDA is a huge recognition, and it will promote our efforts to bring VCFix® to patients.This development has significantly accelerated our timeline, and our first human clinical trial is expected to begin in early 2022 Europe And the United States, let us get closer to improving the quality of life of patients with vertebral fractures. “
Every year, more than 1.5 million people suffer from vertebral fractures, which causes severe back pain, inconvenience, and an increase in the mortality rate of the already fragile elderly population. Currently, these injuries are treated by injecting PMMA bone cement into the vertebrae, and 65% of patients face different types of side effects after treatment.
The VCFix® Spine System is the first solution to treat vertebral fractures without relying on bone cement. Through its 3D printed perforated structure, VCFix® implants are designed to stimulate bone ingrowth, making it a more natural healing process, while providing better stability and better spinal load distribution. Amber Implants’ commitment is to bring simpler, more effective and safer fracture treatment methods to the market.
About amber implants
Amber Implants is a medical technology company located in Dutch with AmericaEstablished in 2018, the company has developed the next generation of spinal implants for vertebral compression fractures (VCF), and focused on improving patient treatment outcomes by providing more natural healing and stable implants. Amber Implants uses Additive Manufacturing (AM) and higher precision CNC technology to develop novel and revolutionary expandable implants to create unique solutions for spine and other orthopedic diseases.
The VCFix® Spine System is the first cementless solution for the treatment of various vertebral fractures. Through its 3D printed perforated structure, VCFix® implants are designed to stimulate bone ingrowth and provide a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical repair. VCFix® implants provide pedicle anchoring to achieve better stability, better distribution of loads in the middle and posterior columns of the spine, and the possibility of posterior fixation for more unstable fractures. The VCFix® spine system is equipped with a user-friendly disposable sterile surgical kit that enables perfect traceability and reduces the risk of infection. VCFix® will become a new generation of easier, more effective and safer treatment for patients with vertebral fractures.
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Source Amber Implant