SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices
FREMONT, Calif., Oct. 10, 2018 /PRNewswire/ -- SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device.
The LLIF procedure uses minimally invasive techniques that approach the spine from the side of the patient, allowing for a larger implant footprint, and less disruption to lower back muscles as compared to other approaches, which results in less blood loss and faster recovery.
Sagittae is a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It is designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates.
The ability to personalize the device to each patient's needs provides restorative independent height and lordotic angle with proper anatomical fit. Available in five sizes, all with independent parallel height or lordotic profiles, Sagittae provides several options for surgeons to address optimal sagittal balance, while minimizing burdensome implant inventory traditionally required for each procedure.
"Sagittae is a personalized, expandable spinal implant with intra-operative adjustability ability for any height and any lordotic angle needed in a patient's specific anatomy. This new lateral cage minimizes the need to forcefully impact the cage into the disc space," said Roy Chin, Executive Chairman and CEO of SpineEX.
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