02 Sep MiRus Receives FDA 510(K) Clearance For The Lowest Profile and Best-in-class Expandable Lumbar Interbody
ATLANTA, Aug. 31, 2021 /PRNewswire/ — MiRus LLC, the leading innovator in rhenium-based superalloy medical implants announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IO™ Expandable Lumbar Interbody.
The IO™ Expandable Lumbar Interbody can be utilized in both PLIF and TLIF 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. 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. Powered by the MoRe® expansion engine, the IO™ Expandable Lumbar Interbody allows minimization of insertion height and maximization of expansion height, lordosis thus making it easier for surgeons to restore lordosis, maintain sagittal balance while reducing the challenges of insertion and related neural injury.
“The FDA approval of the IO™ Expandable Lumbar Interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery” said Jay S. Yadav MD, Founder and CEO, “it also marks a significant milestone in our development of complex rhenium-based medical implants.”
Mahesh Krishnan, Chief Commercial Officer stated, “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.
About MiRus, LLC.
MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Find out more information about MiRus at www.mirusmed.com.
* MiRus ™, IO™ are all trademarks of MiRus, LLC.
|Mahesh Krishnan||Pam Cowart|
|Chief Commercial Officer||VP of Clinical Affairs|