SECURE®-C technical overview
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Cervical Artificial Disc TECHNICAL OVERVIEW

Cervical Artificial Disc SECURE®-C is designed to preserve motion for patients suffering from intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. Superior Results SECURE®-C demonstrated statistical superiority in overall success to Anterior Cervical Discectomy and Fusion (ACDF) in the multicenter IDE clinical trial. The device provides patients the potential for motion preservation versus a rigid fusion with an ACDF. In addition, mean Neck Disability Index and mean Visual Analog Scale (VAS) neck and arm pain scores showed postoperative...

Natural Biomechanical Motion Axial Rotation The natural motion of the cervical spine is comprised of three primary motions: flexion–extension, lateral bending and axial rotation. Sagittal plane translation has also been identified as a significant component of cervical motion.1 C5-C6 Motion1 Flexion–Extension Sagittal Plane Translation Lateral Bending Axial Rotation Selectively Constrained Design SECURE®-C is designed to allow ±15° flexion–extension Spherical Interface motion, ±10° lateral bending motion, unconstrained axial rotation, and ±1.25mm translation. The spherical and cylindrical...

Biomechanical Motion A biomechanical cadaver study2 was conducted to compare the range of motion (ROM) of SECURE®-C to the intact cervical spine in flexion–extension, lateral bending and axial rotation. The results show that SECURE®-C may be capable of maintaining motion similar to the natural cervical spine. Study Design 7 cadaveric spine specimens Hybrid test protocol — 1.5Nm moment — Flexion/Extension (F/E) — Lateral Bending — Axial Rotation Tested intact spine Tested spine with SECURE®-C at C5-6 Results normalized to the intact spine SECURE®-C may maintain motion similar to that of the...

Clinical Motion The multicenter IDE clinical trial demonstrated that 85% of patients treated with the SECURE®-C who returned for 24 month follow-up had >4° of flexion-extension motion or maintenance of motion relative to the preoperative baseline. Patients demonstrated an average flexion-extension range of motion of 9.3° and sagittal plane translation Motion Outcomes SECURE®-C may provide a motion profile similar to that of the natural spine. SECURE®-C is designed to permit sagittal plane translation without rigidly constraining the center of rotation. For more information please refer to...

Additional Attributes In addition to allowing the potential for cervical motion, SECURE®-C is designed to facilitate a streamlined procedure, promote bony fixation and minimize wear debris. Initial fixation from multiple serrated keels Titanium plasma spray coating designed to allow for bony ongrowth Single step insertion facilitated by endplate recess feature Ultra-high molecular weight polyethylene (UHMWPE) core designed to minimize wear debris Engagement recess designed to secure core between endplates SECURE®-C 24 Month Post-op Neutral Position 5 | SECURE®-C Technical Overview Endplates...

Streamlined Procedure Our exclusive instruments and streamlined procedure are designed to allow precise placement of the implant with only three essential steps: Trial—Chisel—Insert. Identify the proper size to match the patient’s anatomy Specialized chisels designed to reduce trauma during chiseling Entire assembly inserted at once SECURE®-C Technical Overview | 6

Particulate Study Polyethylene wear particles can form and migrate throughout the life of articulating devices such as SECURE®-C. To evaluate the effect of wear debris in the epidural space, a particulate animal study was conducted. Objective The purpose of the study was to evaluate the local and systemic effect of ultra-high molecular weight polyethylene (UHMWPE) particles implanted into the epidural space of New Zealand white rabbits. Spinal Cord of Control Rabbit at 6 months Study Details Control Group (n=12) — Epidural space injected with saline Low Dose Group (n=12) — Epidural space...

Mechanical Testing Durability SECURE®-C is manufactured from proven materials used in total joint arthroplasty for decades.6 Highly polished cobalt-chrome-molybdenum alloy (CoCrMo) endplates articulate with an ultrahigh molecular weight polyethylene (UHMWPE) core. The combination of these materials achieves wear rates similar to that reported for other metal-on-polyethylene cervical discs, under wear simulation studies.7 Wear testing was performed on SECURE®-C using a combined motion profile and a constant 150N axial load. Wear rates were relatively constant, remaining below 1mm3 per...

Indications for Use The SECURE®-C Cervical Artificial Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single‐level discectomy for intractable radiculopathy (arm pain and/or functional or neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X‐rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height. The SECURE®-C...

Comprehensive Implant Offering SECURE®-C is offered in two lordotic profiles and three endplate sizes to accommodate varying patient anatomy. The implants are available in heights of 7–12mm as measured from the anterior side. Posterior height for the 6° profile is 1mm less than the anterior height. SECURE®-C Technical Overview | 10

Globus Medical Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 www.globusmedical.com ©2012 Globus Medical. All rights reserved. Patents pending. Life moves us is a trademark of Globus Medical. SECURE is a registered trademark of Globus Medical. Please refer to the package insert for description, indications, contraindications, warnings, precautions and other important information. Customer Service: Phone 1-866-GLOBUS1 (or 1-866-456-2871) Fax 1-866-GLOBUS3 (or 1-866-456-2873) : RMS – UK Limited 28 Trinity Road, Nailsea, Somerset, BS48 4NU England