Silver Bullet’s OrthoFuzlon Bone Screw System Earns CE Mark Approval
Silver Bullet Therapeutics has received a CE mark for its antimicrobial OrthoFuzlon Cannulated Bone Screw System, the world’s first available antimicrobial bone screw system. The company plans on a limited European release of the MRI-compatible OrthoFuzlon system within the next few months.
Implanted like a traditional bone screw, OrthoFuzlon is comprised of a platinum-plated cannulated titanium bone screw and silverplate nitinol insert that fastens into the inner lumen of the screw cannula. Once implanted, the system produces silver ions that reduce microbial contamination.
Compared with standard bone screws, OrthoFuzlon adds greater resistance to pull-out forces while eliminating microbial contamination on the device’s inner and outer surface, said Silver Bullet co-founder Bohdan Chopko in announcing the approval Wednesday.
In vitro testing yielded bactericidal results against several common pathogens, including MRSA, the San Jose, Calif., company said.
According to a recent report by the Britain’s National Health Service, up to 25 percent of open fracture cases contend with infection, with poor or delayed care leading to amputation. Paul Chirico, president and CEO of Silver Bullet, estimates that MRSA treatments alone add $34 billion to the U.S. healthcare system.
OrthoFuzlon is Silver Bullet’s first commercial product. — Jason Scott