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, Co-founder 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.