FDA Clearances

510(k) for Astura Medical's Lateral Lumber Interbody Fusion System, Cagent Vascular's balloon catheter treats BTK lesions, SonoVision ultrasound platform from Tissue Differentiation Intelligence.

Published June 24, 2020
Astura Medical received 510(k) clearance 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 offers intraoperative flexibility and efficiency with a procedural solution for lateral surgery based on surgeon preference. Developed internally to ensure intricate design details and quality benchmarks, the Sirion retractor allows for customized access with a 2- or 3-blade configuration, each blade having infinite, independent distraction and toeing capability. An optional anterior blade is available in multiple widths, and various shims and bone pins allow surgeons to tailor retractor access and rigidity to each patient’s needs.

Cagent Vascular received FDA 510(k) clearance of its Serranator PTA Serration balloon catheter for treating below-the-knee (BTK) lesions. The Serranator angioplasty balloon device is FDA cleared and CE marked, embedding serration technology into a semi-compliant balloon for treating peripheral artery disease (PAD). It’s designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.

 

Tissue Differentiation Intelligence LLC (TDi) received 510(k) clearance for the SonoVision ultrasound platform designed for intraoperative access to the spine. Applying layers of image-processing algorithms to ultrasound images collected intraoperatively allows SonoVision to visually differentiate nerve, muscle, bone, and vessels in real time. FDA clearance will allow ultrasound to be used in imaging for spine surgery.
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