Astura Medical Receives FDA 510(k) Clearance For SIRION Lateral Lumbar Interbody Fusion System
IRVING, TX – April 14, 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 Sirion Lateral Lumbar Interbody Fusion (LLIF) System.
From initial access with the retractor to the interbody and plating options, the Sirion LLIF System delivers unprecedented intraoperative flexibility and efficiency by providing a complete procedural solution for lateral surgery driven by surgeon preference.
“Since the outset of the design process, our goal was to develop a system that could address the wide array of procedural and anatomical challenges presented in lateral surgery,” said Thomas Purcell, Cofounder and Vice President. “Once again, our surgeon design partners and engineering team have exceeded expectations to bring another best-in-class MIS platform to market.”
The Sirion retractor was developed internally to ensure the intricate design details and quality benchmarks that the company has become renowned for were achieved. This resulted in a retractor that allows for access customization by offering a 2 or 3 blade configuration, with each blade having infinite, independent distraction and toeing capability. An optional anterior blade is also offered in multiple widths, as well as various shims and bone pins to allow surgeons the ability to further tailor the access and rigidity of the retractor to the unique needs of each patient.
Building from the well-established success of previous systems within the company’s portfolio, Sirion provides interbody spacers in either HA PEEK or Acid-etched Ti in a wide range of lengths, widths, heights, and lordotic options. When additional fixation is required, lateral plating options in either a 1, 2, or 4 hole configuration are available, which can be implanted in combination with the interbody or in-situ after the interbody has been placed for maximum versatility.
The launch of Sirion represents the first platform from Astura with a combined interbody and fixation option in a single system. The company is scheduled to release additional combined technology for Anterior Lumbar Interbody Fusion (ALIF) and Anterior Cervical Discectomy Fusion (ACDF) in the coming months.
For more information on the Sirion LLIF 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
