Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan Oblique anterior lumbar interbody fusion (ALIF) system.
According to the company, El Capitan Oblique was specifically designed to deliver the widest array of construct options with the most efficient and streamlined supporting instrumentation in the oblique anterior lumbar surgery marketplace.
Thomas Purcell, co-founder and vice president of Astura Medical, said: “With the rising demand for technology to provide anterior column reconstruction beyond traditional anterior and lateral lumbar approaches, we set out to provide a system that would establish a higher benchmark for intraoperative versatility, flexibility, and efficiency in oblique anterior lumbar surgery
“Thanks to the hard work and ingenuity of our engineering team and surgeon design partners, we were able to achieve our goal by delivering another best-in-class technology to our portfolio of solutions.”
El Capitan Oblique is the first system to provide multiple, customisable plating and fixation options in oblique anterior lumbar procedures, the company claims. Astura add that the plating options from El Capitan Oblique allow for either a zero-profile, half plate, or full plate that can be implanted in combination with the interbody from either a left or right sided approach. By providing either anchoring nails or screws, which can be delivered via multiple techniques including an all-in-one option, El Capitan Oblique can accommodate the wide variance of anatomical challenges presented in oblique anterior lumbar surgery.
El Capitan Oblique is the company’s fourth technology platform providing a combined interbody and fixation option to receive 510k approval.