MiRus Gets FDA Breakthrough Nod for Europa Spine Implant

MiRus has earned breakthrough status from the U.S. Food and Drug Administration (FDA) for its Europa posterior cervical system. The spine implant is based on the company’s proprietary rhenium alloys and treats the cervical and upper thoracic spine.
 
The Europa PCF is built around a 2.9 mm MoRe rod that the company said is much smaller than current commercial systems. The lower diameter rod allows use of low-profile screw tulips, which can lead to less invasive surgery and less hardware prominence in patients that are smaller.
 
The company also claims the lower diameter MoRe rods still offer superior rigidity, strength, and fatigue resistance to their larger counterparts.
 
“Currently the rates of spine implant failures and revision surgeries for patients remain unacceptably high,” said Jordan Bauman, MiRus’ VP of regulatory and quality. “With EUROPA 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.”
 
In October, the company received FDA 510(k) clearance for its Cygnus MoRe anterior cervical plate and MiRus 3DR lateral lumbar interbody fusion (LLIF) system with integrated MoRe plate fixation.