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Amber Implants has completed enrollment of its first-in-human clinical trial with its innovative VCFix Spinal System. VCFix is the first device that does not rely on bone cement for the treatment of vertebral compression fractures.
The study enrolled 10 patients, all of whom suffered from severe disabling pain with Disability Ratings of 70% and higher. Following the procedure, typically lasting less than 20 minutes, all patients saw maximal pain reduction with Disability Ratings reduced to 10% or less and they were able to walk freely without disability at discharge. The short-term efficacy data, as well as the performance of the device, has shown promising results and will be further assessed in the continuation of this trial.
Amber will soon begin the pivotal clinical trial for the same intended use (i.e., standalone and with and without cement) as well as test the device with a posterior fixation method for high-energy traumatic fractures. Amber is preparing for these pivotal trials in a broader European setting before the end of the year and is building toward FDA clearance for its first indication in early 2025.
VCFix offers a strategy to manage vertebral fractures, with and without cement and with and without posterior fixation. It can be used for a broad range of indications, from osteoporotic low-energy fractures to traumatic high-energy fractures.
Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, said, “Short-term efficacy data from the study is very promising, with results even exceeding our expectations. Patients have experienced significant pain relief and regained the ability to walk without discomfort. VCFix has the potential to be a disruptive technology for the millions of patients who suffer from vertebral fractures each year. We are now focused on preparing for pivotal trials in Europe to bring the benefits of this technology to the many more patients who would otherwise suffer from the high rate of complications associated with other treatment options available.”
The VCFix Spinal System received a breakthrough designation from FDA in 2021.
Source: Amber Implants
Amber Implants has completed enrollment of its first-in-human clinical trial with its innovative VCFix Spinal System. VCFix is the first device that does not rely on bone cement for the treatment of vertebral compression fractures.
The study enrolled 10 patients, all of whom suffered from severe disabling pain with Disability Ratings of...
Amber Implants has completed enrollment of its first-in-human clinical trial with its innovative VCFix Spinal System. VCFix is the first device that does not rely on bone cement for the treatment of vertebral compression fractures.
The study enrolled 10 patients, all of whom suffered from severe disabling pain with Disability Ratings of 70% and higher. Following the procedure, typically lasting less than 20 minutes, all patients saw maximal pain reduction with Disability Ratings reduced to 10% or less and they were able to walk freely without disability at discharge. The short-term efficacy data, as well as the performance of the device, has shown promising results and will be further assessed in the continuation of this trial.
Amber will soon begin the pivotal clinical trial for the same intended use (i.e., standalone and with and without cement) as well as test the device with a posterior fixation method for high-energy traumatic fractures. Amber is preparing for these pivotal trials in a broader European setting before the end of the year and is building toward FDA clearance for its first indication in early 2025.
VCFix offers a strategy to manage vertebral fractures, with and without cement and with and without posterior fixation. It can be used for a broad range of indications, from osteoporotic low-energy fractures to traumatic high-energy fractures.
Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, said, “Short-term efficacy data from the study is very promising, with results even exceeding our expectations. Patients have experienced significant pain relief and regained the ability to walk without discomfort. VCFix has the potential to be a disruptive technology for the millions of patients who suffer from vertebral fractures each year. We are now focused on preparing for pivotal trials in Europe to bring the benefits of this technology to the many more patients who would otherwise suffer from the high rate of complications associated with other treatment options available.”
The VCFix Spinal System received a breakthrough designation from FDA in 2021.
Source: Amber Implants
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
