Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan Anterior Lumbar Interbody Fusion (ALIF) System.
El Capitan was designed to provide the widest array of interbody and fixation options, along with the most efficient and streamlined supporting instrumentation on the market today, Astura Medical said in a press release.
“With the increased adoption and utility of anterior column reconstruction, we aimed to provide a system that accommodates the demanding clinical needs for this procedure,” said Thomas Purcell, the company’s co-founder and vice president. “Our surgeon design partners and engineering team addressed the current technological gaps in efficiency while incorporating additional fixation versatility into a single system to deliver another best-in-class technology to our ever-growing portfolio of solutions.”
Expanding on the foundation of success from the company’s previous interbody spacer technologies, El Capitan provides the choice of either HA PEEK or Acid-etched Titanium interbody spacers in an extensive array of heights, widths, and lordotic options.
The system also provides the flexibility for additional plating and fixation options in an effort to tailor to the specific needs of each patient. The plating options from El Capitan allow for a zero-profile, half plate, or full plate that can be implanted in combination with the interbody. By providing either anchoring nails or screws, which can be delivered via multiple techniques including an all-in-one option, El Capitan can accommodate the wide variance of anatomical challenges presented in anterior lumbar surgery.
El Capitan is the company’s second technology platform providing a combined interbody and fixation option to receive 510k approval within the last month. Later this year, the company is scheduled to release another combined technology for Anterior Cervical Discectomy Fusion (ACDF).