MiRus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its IO Expandable Lumbar Interbody, a device which can be used in both posterior lumbar interbody fusion and transforaminal lumbar interbody fusion procedures.
It features the lowest insertion profile (4mm) and greatest expansion (18mm) and lordosis (24◦) in a single implant of any expandable interbody on the market, according to MiRus. In addition to the one step expansion, the expandable implant allows for 2.5cc of biologic to be post-packed in the inter-vertebral space.
Jay Yadav, founder and CEO of MiRus, said: “The FDA approval of the IO Expandable Lumbar Interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery. It also marks a significant milestone in our development of complex rhenium-based medical implants.”
Chief commercial officer, Mahesh Krishnan, added: “IO continues the MiRus philosophy of using the MoRe superalloy to create implants that objectively exceed the specifications of the existing market leading products; this delivers immense value to surgeons and patient care. The expandable interbody market is saturated with pedestrian implants that are limited by the mechanical and biological properties of titanium and cobalt chromium, compromising usability as well as performance.
“The upcoming launch of the IO Expandable Lumbar Interbody will meet the significant demand of our surgeons and distribution channels who have long anticipated a lower profile and best-in-class expandable interbody. We are also excited to be working with leading surgeons to expand our portfolio with lateral expandable, TLIF curved expandable, ALIF expandable and expandable corpectomy cages, all built on the MoRe expansion engine.”
FDA 510(k) clearance allows the IO Expandable Lumbar Interbody to be used in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L1-L2 to L5-S1.