Salt Lake City, Utah-based Amedica announced Thursday that it has received regulatory clearance for the second generation of an interbody fusion device system.
The U.S. Food and Drug Administration has cleared itscervical and lumbar interbody fusion devices (IBF) made with a proprietary biomaterial. These devices and their design improvements will help surgeons perform minimally invasive procedures when doing lumbar lateral interbody fusion.
The silicon nitride biomaterial contained in the interbody fusion device helps in the accurate placement of the spinal implant because it is semiradiolucent. Clinical tests have shown that the company’s silicon nitride biomaterial enables better integration of the bone with the implant and has superior anti-infective qualities when compared with competing products that use titanium or polyether ether ketone.
Taking the minimally invasive approach to lumbar lateral interbody fusion can help reduce operative time, postoperative pain as well as length of hospital stay. It can also facilitate a faster recovery of patients who can resume their normal lives.
“Amedica is now better positioned to deliver a technology that can change the standard of care for spinal surgery,” said Eric Olson, Amedica’s president and CEO, in a news release. “The enhancements we have made to our interbody line of products including the LLIF devices speak to our long-term commitment to improve interbody fusion procedures by providing a premium product that enhances the surgeon experience while dramatically improving patient outcomes.”
The lumbar lateral interbody fusion market is valued at $147 million and plays in the much larger $1.5 billion interbody fusion market, according to Amedica.The products are expected to launch in the fourth quarter.