Sam Brusco, Associate Editor10.03.23
Amber Implants, a Netherlands-based company developing next-gen implants for spinal injuries, has begun clinical trials for its VCFix spinal system.
The VCFix implant is used to manage a diverse range of vertebral fractures and the company believes it can remove the need for Polymethyl methacrylate (PMMA) bone cement bone cement for treatment, with continued compatibility. VCFix was designed for both single- and multi-level posterior fixation. The implant seeks to optimize load distribution in the spine via pedicle anchorage.
The first-in-human trial will evaluate VCFix’s safety and efficacy for patients with vertebral compression fractures. It’s also included with a single-use, sterile surgical kit to ensure traceability and reduce infection risk.
The study is being led by Prof. Dr. Robert Pflugmacher, at the Clinic for Orthopaedics of the Mechernich Hospital in Germany. He said he was “very pleased with the device's performance regarding the ease of the procedures and the initial results for the patient,” according to a press release.
Amber Implants’ co-founder and CEO Dr. Banafsheh Sajadi added, "This news marks a key milestone in the product development of the VCFix Spinal System, and we aim to expand the clinical trial to further validate the device's versatile applications. Our comprehensive approach is a significant leap forward in spinal healthcare, promising safer and more effective treatments for patients with both traumatic and osteoporotic vertebral fractures."
The VCFix spinal system received U.S. Food and Drug Administration (FDA) designation as a breakthrough device in October 2021.
The VCFix implant is used to manage a diverse range of vertebral fractures and the company believes it can remove the need for Polymethyl methacrylate (PMMA) bone cement bone cement for treatment, with continued compatibility. VCFix was designed for both single- and multi-level posterior fixation. The implant seeks to optimize load distribution in the spine via pedicle anchorage.
The first-in-human trial will evaluate VCFix’s safety and efficacy for patients with vertebral compression fractures. It’s also included with a single-use, sterile surgical kit to ensure traceability and reduce infection risk.
The study is being led by Prof. Dr. Robert Pflugmacher, at the Clinic for Orthopaedics of the Mechernich Hospital in Germany. He said he was “very pleased with the device's performance regarding the ease of the procedures and the initial results for the patient,” according to a press release.
Amber Implants’ co-founder and CEO Dr. Banafsheh Sajadi added, "This news marks a key milestone in the product development of the VCFix Spinal System, and we aim to expand the clinical trial to further validate the device's versatile applications. Our comprehensive approach is a significant leap forward in spinal healthcare, promising safer and more effective treatments for patients with both traumatic and osteoporotic vertebral fractures."
The VCFix spinal system received U.S. Food and Drug Administration (FDA) designation as a breakthrough device in October 2021.