SpineEX Receives Additional FDA Clearance for Innovative Sagittae Lateral Lumbar Interbody Fusion System
FREMONT, Calif., March 25, 2019 (GLOBE NEWSWIRE) — SpineEX, Inc., a medical device company focused on the design, development and marketing of products for spine disorders, received an additional U.S. Food and Drug Administration (FDA) clearance for its innovative Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. This additional 510(k) clearance will enhance SpineEX’s ability to achieve full-scale commercialization. The Company received the initial FDA clearance in October 2018.
“We believe the positive feedback and robust interest we are getting from surgeons for our innovative Sagittae Lateral Lumbar Interbody Fusion (LLIF) device validates our technology, while the operational progress we continue to make positions SpineEX for long term sustainable growth and success.” commented Roy Chin, Chairman and Chief Executive Officer. “We expect, in the very near future, to announce the first procedure using our innovative Sagittae device to be performed by a leading orthopedic surgeon and complete our transition from a development stage to a commercial stage and revenue generating company.”
The additional 510(k) clearance for the Company’s Sagittae Lateral Lumbar Interbody Fusion (LLIF) covers:
- The addition of new system instrumentation along with an updated surgical technique.
- Enables surgeons to better streamline the implant sizing process along with giving surgeons the ability to adjust the anterior and posterior side of the implant independently of one another.
- The clinical end goal of Sagittae is to help achieve optimal lordosis, vertebral endplate contact, and posterior column decompression to give each patient the best personalized implant configuration possible.
Since receiving the initial FDA clearance, the Company has been working with several long-term suppliers to manufacture the Sagittae cages and instrumentation, in preparation for the Company’s commercialization efforts, which are expected to commence later this month.
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.
SpineEX, Inc. is a medical device company that specializes in providing innovative and minimally invasive implants, high value disposables and devices in spinal fusion surgeries. SpineEX is committed to continuously innovating, improving, and expanding its product line to accommodate any and all surgeons, methods, and areas of spinal fusion on a global scale.
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