MiRus receives FDA breakthrough device designation for posterior cervical spine system
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Key takeaways:
- MiRus received FDA breakthrough device designation for its Europa posterior cervical system.
- The system features a smaller-diameter alloy rod for patients undergoing minimally invasive spinal fusion.
MiRus announced it received FDA breakthrough device designation for its Europa posterior cervical system for patients undergoing cervical and upper thoracic spinal fusion, according to a press release.
The Europa posterior cervical system is designed with a smaller-diameter alloy rod for minimally invasive surgery, according to the release.
“Currently, the rates of spine implant failures and revision surgeries for patients remain unacceptably high,” Jordan Bauman, vice president of quality and regulatory affairs at MiRus, said in the release. “With Europa [posterior cervical fusion] PCF, spine surgeons will be able to provide durable and less invasive surgery for their cervicothoracic patients. This is another step forward in our mission to provide less invasive and more durable devices across a broad spectrum of disease states.”
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