MiRus receives FDA 510(k) clearance for expandable lumbar interbody implant
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MiRus LLC has received FDA 510(k) clearance for its IO expandable lumbar interbody implant for use in patients with degenerative disc disease, according to a press release.
The IO implant is a rhenium-based superalloy, expandable interbody, designed for a variety of lumbar interbody fusion procedures, according to the release.
“The FDA approval of the IO expandable lumbar interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery,” Jay S. Yadav, MD, founder and CEO of MiRus, said in the release. “It also marks a significant milestone in our development of complex rhenium-based medical implants.”
“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,” Mahesh Krishnan, chief commercial officer of MiRus, said in the release. “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,” Krishnan added.
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