Birmingham, AL, August 21, 2023 /OrthoSpineNews/ – Alevio® Backbone, a frontrunner within the therapy of sacropelvic situations, at present introduced 510(okay) clearance of extra choices for the SI-Treatment® Implant household. The clearance (K231951) provides headless screws and a variety of extra screw dimension choices to the beforehand cleared system.
The SI-Treatment Implant was conceived and designed to optimize the therapy of sufferers with SI joint ache by offering compression, fixation and fusion. The corporate has greater than 5-years of scientific expertise utilizing a simple and clinically confirmed method. By specializing in fusion, the SI-Treatment Implant gives sufferers the potential for excellent outcomes.
The SI-Treatment Basis™ assemble gives a confirmed choice for sufferers who’re present process sacropelvic fixation as a part of a lumbar or thoracolumbar fusion. A Retrospective Cohort Research utilizing the SI-Treatment Implants reported that simultaneous SIJ instrumentation and fusion lower the chance of incapacity, forestall the event of postoperative SIJ ache, and may additionally defend the S2AI screw from loosening and failure.1
SI-Treatment Implant System Highlights:
- Patented design gives graft contact alongside the size of the Implant.
- Encompasses a Self-Harvesting™ design that collects autograft because the Implant is superior, thus eliminating the necessity for bone graft.
- Because the Implant is superior, the helical design pushes the bone into the open structure of the implant permitting the Self-Advancing™ autograft to backfill the size of the Implant.
Alevio Backbone has a strong and rising portfolio of methodology and design patents. These patents cowl options together with self-harvesting, self-advancing, and an open structure helical pathway. The SI-Treatment Sacroiliac Joint Fusion System consists of titanium Implants of 7mm, 8.5mm, 9.5mm, 10.5mm, and 11mm diameter with lengths from 35-110mm to accommodate affected person anatomy. An optionally available serrated washer might be positioned on the screw head for load distribution. The screws are comprised of titanium alloy Ti-6AL- 4V ELI per ASTM F136.
Indications for Use The SI-Treatment Sacroiliac Joint Fusion System is meant for sacroiliac fusion for the next situations:
- Sacroiliac joint dysfunction that could be a direct results of sacroiliac joint disruption and degenerative sacroiliitis. This contains situations whose signs started throughout being pregnant or within the peripartum interval and have endured postpartum for greater than 6 months.
- To enhance immobilization and stabilization of the sacroiliac joint in skeletally mature sufferers present process sacropelvic fixation as a part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
About Alevio Backbone
Alevio, LLC is a quick rising, privately held medical machine firm positioned in Birmingham, Alabama. Alevio works intently with healthcare professionals to create remedies that profit sufferers who’ve sacropelvic situations and improve the follow of drugs. To study extra go to: www.aleviospine.com
References:
- Noureldine MHA, Farooq J, Kumar JI, et al. Improved Outcomes with Concurrent Instrumentation and Fusion of the Sacroiliac Joint in Sufferers with Lengthy Lumbosacral Constructs [published online ahead of print, 2022 Jan 10]. World Backbone J. 2022;21925682211069095. doi:10.1177/21925682211069095
©2023 Alevio, LLC. Alevio, SI-Treatment, SI-Treatment Basis, Self-Harvesting, Self-Advancing, and Shifting Life Ahead are emblems of Alevio, LLC FRM-072 Rev. A
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