Astura Medical Receives FDA 510(k) Clearance For El Capitan Lumbar Interbody Fusion System
IRVING, TX – April 30, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. 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.
“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, 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).
For more information on the El Capitan ALIF System, click here.
About Astura Medical
Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.
The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.
For more information, please visit www.asturamedical.com or find us on LinkedIn.
Media Contact:
Steve Haayen
Astura Medical
858.472.8825
