Medical device company Silver Bullet Therapeutics Inc reported on Thursday the receipt of recommendation for CE Mark approval for the commercial sale of its antimicrobial OrthoFuzIon Bone Screw System in the EU.
The OrthoFuzIon System is used for for orthopaedic reduction and internal fixation procedures in the body.
The new CE Mark approval includes screws for use in orthopaedic, spinal, dental and maxillofacial procedures.
In the coming months, the company will be finalising launch plans with its prospective partners for selected European markets.
According to the company, OrthoFuzIon Orthopedic Bone Screw System is the world's first regulatory-approved antimicrobial bone screw product for orthopaedic procedures. The system expands upon the cannulated screw system and includes both solid and cannulated titanium bone screws.
Coated with Silver Bullet's proprietary AntiBacterIon coating, the bone screws facilitate sustained silver ion release. The AntiBacterIon coating provides antimicrobial protection to an implanted device. Silver ions are deadly to all forms of bacteria locally, even antibiotic resistant species, yet non-toxic to humans except in extremely high doses.
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