Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan X expandable anterior lumbar interbody system.
El Capitan X is a leap forward for what is now possible for anterior lumbar interbody fusion (ALIF) systems, say Astura Medical, adding that the system provides a complete range of expandable anatomic spacers and fixation options with infinitely adjustable expansions in height and lordosis up to 30° for a unique, patient-specific solution.
According to the company, El Capitan X’s intuitive design delivers a comprehensive range of infinitely adjustable construct options and expansive instrumentation that provide the versatility to address even the most complex anatomical challenges in a streamlined, efficient procedural sequence.
Thomas Purcell, co-founder and vice president of Astura Medical, said: “The approval of El Capitan X represents a new benchmark for what’s possible in the anterior lumbar fusion marketplace. By becoming the first and only system to combine integrated plate and spacer options, along with customisable expandable interbody capabilities, the system delivers on our goal of providing more intraoperative flexibility and versatility than any other ALIF system on the market. El Capitan X is redefining what it means to deliver a truly patient-specific solution.”
El Capitan X is Astura Medical’s first expandable technology platform with multiple fixation configurations to receive 510k approval. The company is scheduled to release El Capitan Oblique ALIF later this spring as well as introduce several new, expandable technologies in the coming months.