MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody.
Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24-degree lordosis.
“The FDA approval of the IO expandable lumbar interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery,” founder and CEO Jay Yadav said in a news release. “It also marks a significant milestone in our development of complex rhenium-based medical implants.”
The one-step expandable implant allows for 2.5cc of biologic to be post-packed in the intervertebral space. It also allows for minimization of insertion height and maximization of expansion height, lordosis to make it easier for surgeons to restore lordosis, maintain sagittal balance and reduce insertion and related neural injury challenges, according to the company.
“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,” Chief Commercial Officer Mahesh Krishnan said. “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.”
IO is cleared for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L1-L2 to L5-S1.