RISSKOV, Denmark--(EON: Enhanced Online News)--The innovative Danish medical device company, FBC Device, has received CE mark for its first spinal fusion implant, the Statur®-L, and ISO certification demonstrating the company’s adherence to the highest quality standards. With these accomplishments, the company can now introduce its pioneering spinal fusion device to the European and Canadian markets.
“We are very pleased to have achieved both ISO 13485 and CE mark”
“We are very pleased to have achieved both ISO 13485 and CE mark”, states Prof. Finn Bjarke Christensen, Founder and CEO. “We are committed to produce innovative and high quality spinal implants supported by significant experimental and clinical documentation”. The ISO certification evaluates the business’s adherence to quality standards, while the CE mark ensures that the device conforms to safety and performance requirements. “Attaining CE mark on our first product line allows us to start clinical activity at leading European spine centers to document the benefits for chronic low back pain patients, surgeons and hospitals”, Mr Christensen continues.
The Statur-L is a hybrid of fusion and non-fusion technology, taking the best from both surgery approaches to potentially benefit the patient, the surgeon, the hospital and the medical device company. Surgeons gain a better way to address the loss of spinal curvature common in patients undergoing fusion. According to research, the loss of curvature is linked to back pain and restoration of the curvature is linked to better results for patients undergoing fusion surgery. In addition, the novel design reduces the number of implants needed, benefiting the hospital and the medical device company.
Data recently presented at both the EuroSpine Annual Meeting in Liverpool and the German Congress of Orthopaedics and Trauma in Berlin supported the positive nature of the Statur-L. Specifically, the research found that the Statur-L reduces relative movement between the implant and the spinal bone. This may ensure that the surgeon’s restoration of curvature during surgery is not lost following surgery. Leading spine biomechanics expert, Prof. Hans-Joachim Wilke from Ulm University, who performed the study, states: “The Statur-L appears capable of solving biomechanical issues associated with existing fusion implants.”
About FBC Device
FBC Device is a knowledge-based company, focussing on intellectual property, product R&D, and clinical documentation for the purpose of commercializing implants with the potential to improve clinical performance. The company partners with a blue-chip supply chain to manage costs and act in an agile manner. The company is managed by a core team with wide experience and network within spinal surgery, clinical research, implant development, marketing and commercialization.