THE HAGUE, Netherlands, June 11, 2024 /PRNewswire/ — Amber Implants (‘Amber’ or ‘the Firm’), an modern medical know-how firm creating next-generation implants for spinal accidents, immediately pronounces that it has accomplished enrollment of its first-in-human medical trial with its modern VCFix® Spinal System. The VCFix® Spinal System is the primary gadget that doesn’t depend on bone cement for the therapy of vertebral compression fractures.
The trial was performed at two facilities in Germany with Prof. Dr. Med. Robert Pflugmacher (Orthopaedic surgeon, Kreiskrankenhaus Mechernich GmbH.) and Dr. Med. Ardeshir Ardeshiri (Neurosurgeon, Wilhelmsburger Krankenhaus Groß-Sand Hamburg) and assessed the security and efficacy of the VCFix® Spinal System for sufferers affected by osteoporotic vertebral compression fractures. The gadget was primarily utilized in stand-alone configuration with out bone cement.
The examine enrolled 10 sufferers, all of whom suffered from extreme disabling ache with Incapacity Rankings of 70% and better. Following the process, sometimes lasting lower than 20 minutes, all of the sufferers noticed maximal ache discount with Incapacity Rankings lowered to 10% or much less and so they have been in a position to stroll freely with out incapacity at discharge.
The short-term efficacy information, in addition to the efficiency of the gadget, has proven promising outcomes and might be additional assessed within the continuation of this trial. Prof. Dr. Med. Robert Pflugmacher mentioned: “VCFix represents a outstanding innovation, considerably enhancing the reconstruction of fractured vertebrae“. “This know-how has confirmed to be user-friendly and has yielded distinctive short-term outcomes for our sufferers”, added Dr. Med. Ardeshir Ardeshiri.
The Firm will quickly start the pivotal medical trial for a similar supposed use (i.e., standalone and with and with out cement) in addition to take a look at the gadget with a posterior fixation technique for high-energy traumatic fractures. Amber is making ready for these pivotal trials in a broader European setting earlier than the top of the 12 months and is constructing in direction of Food and Drug Administration (‘FDA’) clearance for its first indication in early 2025.
Dr. Banafsheh Sajadi, Co-Founder and Chief Govt Officer of Amber Implants mentioned: “Quick-term efficacy information from the examine could be very promising, with outcomes even exceeding our expectations. Sufferers have skilled important ache reduction and regained the flexibility to stroll with out discomfort. VCFix® has the potential to be a disruptive know-how for the hundreds of thousands of sufferers that suffer from vertebral fractures annually. We at the moment are targeted on making ready for pivotal trials in Europe to deliver the advantages of this know-how to the various extra sufferers who would in any other case endure from the excessive fee of problems related to different therapy choices obtainable.”
Per 12 months, over 8.6 million folks endure from several types of vertebral fractures. These fractures trigger extreme again ache, restricted mobility, incapacity, and an elevated fee of mortality. At the moment, vertebral compression fractures are managed by the injection of Polymethyl Methacrylate (PMMA) bone cement into the affected vertebra and/or with multi-level posterior fixation. This may result in unwanted effects in as much as two-thirds of sufferers, post-treatment.
The VCFix® Spinal System is designed to revive the spine and supply most stability to the affected spinal segments. VCFix® provides an modern technique for managing a variety of vertebral fractures, with and with out cement and with and with out posterior fixation. It may be used for a broad vary of indications, from osteoporotic low-energy fractures to traumatic high-energy fractures, and would subsequently be a disruptive know-how for this affected person inhabitants.
The VCFix® Spinal System has acquired a breakthrough designation from the FDA.
CAUTION: This gadget is solely for medical investigation and no substantiated medical advantages have been established.
About Amber Implants
Amber Implants is a medical know-how firm positioned in the Netherlands. Based in 2018, the Firm has developed novel spinal implants for Vertebral Compression Fractures (VCFs) and is targeted on enhancing affected person outcomes by implants that present extra pure therapeutic and higher stability. Amber Implants is dedicated to delivering a brand new era of therapies for traumatic fractures, promising an easier, extra environment friendly, and safer strategy to treating a broader vary of fractures.
SOURCE Amber Implants
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