Amedica Reboots Interbody Fusion Devices with Silicon Nitride

Amedica Corporation, a spinal and reconstructive medical device manufacturer based in Salt Lake City, Utah, has received 510(k) clearance from the U.S. Food and Drug Administration for a second generation family of cervical and lumbar interbody fusion devices (IBF) manufactured with the company’s proprietary silicon nitride biomaterial.

Earlier in September, Amedica expanded its biomaterial claims on one of its interbody devices based on new data on silicon nitride published in the International Journal of Nanomedicine and Acta Biomaterialia. The reports demonstrated superior new bone formation and osteointegration as well as anti-infective properties of silicon nitride in comparison to PEEK and titanium.

Amedica’s new product portfolio expansion offers design enhancements including a threaded insertion feature, additional footprints, and design elements that will allow surgeons to undertake minimally invasive and lumbar lateral interbody fusion (LLIF) approaches.

The most common reason for performing a spinal fusion is to eliminate the pain caused by abnormal motion of the vertebrae as a result of diseased discs, slippage of the vertebrae, or other degenerative spinal conditions, and the goal of the procedure is to immobilize the faulty vertebrae themselves. An interbody fusion device is a prosthesis used in spinal fusion procedures to restore and maintain disc space height following a spinal decompression while fusion occurs. These devices often are filled with bone or other materials in order to promote a spinal fusion at the level that the disc was removed.

This new line of silicon nitride interbody implants gives Amedica a stronger presence in the $1.5 billion IBF market, and allows it to enter the $147 million LLIF space. Minimally invasive LLIF procedures may offer improved patient outcomes by allowing reduced operative time, post-operative pain and hospital stays as well as a rapid return to normal activity, the company reports. Among the challenges in performing an LLIF procedure is the proximity to nerves during implantation, requiring the use of neuromonitoring to ensure precise, safe placement of the implant. Silicon Nitride is semi-radiolucent, which enables an exact view of the implant for precise intraoperative positioning, thereby alleviating this challenge.

“Amedica is now better positioned to deliver a technology that can change the standard of care for spinal surgery,” said Eric K. Olson, president and CEO of Amedica. “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 first products of this family are slated to launch in the fourth quarter of 2012.

Photo of Valeo C and Valeo TL spinal intervertebral spacers made from silicon nitride ceramic courtesy of Amedica.