Eminent Spine

Three and Four-Level ACDFs with Eminent Spine's Anterior Cervical Systems (Cervical Stand-Alone paired with Cervical Plate) Usage Report

Eminent Spine's Cervical Stand-Alone System received FDA 510(K) clearance in November of 2021 and Eminent Spine’s Cervical Plating System received FDA 510(K) clearance in October of 2020. Since then, Eminent Spine’s Anterior Cervical Systems (both Cervical Stand-Alone and Cervical Plate) have reported being used in 12 total 3 and 4-level Anterior Cervical Discectomy and Fusion (ACDF) procedures since September of 2022.

Three and Four-Level ACDFs with Eminent Spine's Anterior Cervical Systems (Cervical Stand-Alone paired with Cervical Plate) Usage Report
Plano, TX, November 28, 2023 --(PR.com)-- Since May of 2022, Eminent Spine’s Cervical Stand-Alone and Cervical Plate implants have been used in 12 total 3 and 4-level ACDF procedures. Of these ACDFs that used Eminent Spine’s Anterior Cervical implants, 4 have been reported to be 3-level procedures, 6 have been reported to be 4-level procedures, 1 has been reported as a 2-level revision with a 3-level plate, and 1 has been reported as a 3-level revision with a 2-level plate. Total Eminent Spine Cervical Stand-Alone implants used in these 3 and 4-level ACDFs are 41. Of these implants, 30 were 3D Titanium and 11 were PEEK.

Eminent Spine’s Anterior Cervical System is comprehensive, solid, and cohesive which allows for ease of use in the OR and effective outcomes. The system includes non-sterile implants with a wide range of instrumentation profiles with both fixed and variable screw options.

The Cervical Stand-Alone implants in Eminent Spine’s Anterior Cervical System are designed with the following: a tapered nose and lordosis which allows for ease of insertion, self-distraction, and aggressive teeth for implant fixation. Micro-teeth on the top faces of the implant prevent micro-migration and micro-motion, and it maximizes anterior cervical fixation avoiding the need of posterior muscle stripping. The locking tab shows visible security of self-tapping, self-drilling screws. These screws include options of 3.5mm, 3.75mm and 4.0mm and range between 10-18mm.

The Cervical Plates in Eminent Spine’s Anterior Cervical System are designed with the following: 1.84mm thickness between levels, 2.04mm designed to reduce potential risk of dysphagia, 17mm wide, friction locking tab prevents migration of screws with locking tabs and screws below the surface of the plate, large graft windows for visual cage confirmation, and sizes available in 1, 2, 3, and 4 levels. There is one universal driver for screws and locking tab which has a pointed drill tip that prevents slipping off the bone (T8/T10 Tip). Screw options include options of 4.0mm and 4.25mm and range between 10-20mm. 14-degree conical rotation is also available with 20-degree hyper-variable per request.

Surgeon’s feedback with 3 and 4-level ACDFs using Eminent Spine’s Systems have been positive regarding the variety of footprints offered, simplicity and reliability of the instrumentation. There have been no reports of screw back-out, screw breakage, cage/plate migration, cage/plate fracture, or malfunction of the locking mechanism. This study of 3 and 4-Level ACDFs using Eminent Spine’s Anterior Cervical Stand-Alone System proves that by utilizing Eminent Spine’s Anterior Cervical System, there is no need for a posterior approach. This minimizes each patient’s chances of complications and morbidity as there is NO posterior muscle stripping. This study has also shown that the Eminent Spine’s Anterior Cervical System can be used to perform a safe and effective ACDF.
Contact
Eminent Spine
Sydney Ewing
972-499-3593
www.eminentspine.com
ContactContact
Categories