MicroPort® Spine Trauma's Full Series Instruments Granted Registration Approval in Brazil
São Paulo, Brazil – Recently, the fracture instruments of Reindeer® Locking Compression Plate System and the instruments of Takin® Spinal Posterior Fixation System, both of which were independently developed by MicroPort Spine Trauma (Suzhou) Medical Technology Co., Ltd. ("MicroPort® Spine Trauma"), successfully received the approval for registration from Agencia Nacional Vigilancia de Sanitaria (ANVISA) of Brazil. It was also the first time that the products of MicroPort® Spine Trauma have been granted the registration approvals in Latin America.
The Reindeer® Locking Compression Plate System is a solution for fracture fixation with locking thread holes, which features precise anatomical design and no pre-bending during the surgery. The LCP combining holes allow this system cooperate with locking and non-locking screws. The Reindeer® Locking Compression Plate System was launched in China in 2014, before starting to explore the overseas market in 2015. It was approved for registration in Italy and South Africa successively in 2015.
Launched in 2015 in China, Takin® Spinal Posterior Fixation System is used to treat the thoracic and Lumbar Spine degenerative diseases, traumas, correction surgeries and tumors, especially with excellent performance in the treatment of the complex diseases of scoliosis and spinal tumor. The system's clinical usefulness and reliability in the challenging spinal surgeries have been confirmed and demonstrated in multiple cases of challenging surgeries. Also, the cortex and cancellous bone thread design and the matching instruments of Takin® Spinal Posterior Fixation System have been highly evaluated by many clinical experts.
With the largest market capacity in Latin America, Brazil is widely known for its high standard, rigorous requirements and long review period when granting access to the country's medical device market. It is expected that the approvals granted to the instruments of two major product lines of MicroPort® Spine Trauma will lay a solid groundwork for the future entry of the company's spine and trauma implant products into the Brazilian market. In future, MicroPort® Spine Trauma will continue to follow the management credo of MicroPort®, which is "Eyes for Greatness, Hands on Details", so as to innovate relentlessly to commercialize the best, yet affordable, therapeutic solutions to save and reshape patients' lives, or to improve their quality of life.
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