Salute e Benessere
Amber Implants Completes Enrolment of First-In-Human Clinical Trial of its VCFix® Spinal System
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 the 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. Prof. Dr. Med. Robert Pflugmacher said: " ". " added Dr. Med. Ardeshir Ardeshiri .
The Company 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 towards Food and Drug Administration ('FDA') clearance for its first indication in early 2025.
Per year, over 8.6 million people suffer from different types of vertebral fractures. These fractures cause severe back pain, limited mobility, disability, and an increased rate of mortality. Currently, vertebral compression fractures are managed through the injection of Polymethyl Methacrylate (PMMA) bone cement into the affected vertebra and/or with multi-level posterior fixation. This can lead to side effects in up to two-thirds of patients, post-treatment.
The VCFix® Spinal System is designed to restore the spine and provide maximum stability to the affected spinal segments. VCFix® offers an innovative strategy for managing a wide range of 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, and would therefore be a disruptive technology for this patient population.
The VCFix® Spinal System has received a breakthrough designation from the FDA.
CAUTION: This device is exclusively for clinical investigation and no substantiated clinical benefits have been established.
Amber Implants is a medical technology company located in the Netherlands . Founded in 2018, the Company has developed novel spinal implants for Vertebral Compression Fractures (VCFs) and is focused on improving patient outcomes through implants that provide more natural healing and better stability. Amber Implants is committed to delivering a new generation of treatments for traumatic fractures, promising a simpler, more efficient, and safer approach to treating a broader range of fractures.
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