Amber Implants Commenced clinical Trial with VCFix | India Pharma Outlook

Amber Implants Commenced clinical Trial with VCFix

India Pharma Outlook Team | Thursday, 05 October 2023

 India Pharma Outlook Team

Amber Implants, a cutting-edge medical technology firm producing next-generation spinal implants, has announced the formal commencement of clinical trials for the VCFix Spinal System. This first-in-human clinical trial will evaluate the safety and efficacy of the VCFix implant in individuals with vertebral compression fractures who do not require bone cement. The implant comes with a simple, single-use sterile surgical kit, guaranteeing complete traceability and lowering the risk of infection. The study is being led by Prof. Dr. Robert Pflugmacher, at the Clinic for Orthopaedics of the Mechernich Hospital in Germany.

He was very pleased with the device’s performance regarding the ease of the procedures and the initial results for the patient, as per pharmabiz. Dr. Banafsheh Sajadi, co-founder and chief executive officer, Amber Implants 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.” Every year, around 8.6 million people suffer from various sorts of spinal fractures. In an already fragile older population, these fractures produce significant back pain, reduced mobility, and a higher likelihood of mortality. Currently, vertebral compression fractures are treated by injecting PMMA bone cement into the afflicted vertebra or by using multi-level posterior fixation. This can result in adverse effects in up to two-thirds of people following therapy.

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