Degenerative Spine Solutions

Transcription

1 Degenerative Spine Solutions The Backbone for Your Surgical Needs Aesculap Spine

2 Backbone for Your Degenerative Spine Needs Comprehensive operative solutions, unique product technology and world-class surgeon education: The backbone of Aesculap s degenerative spine solutions. Aesculap s answer to treating Degenerative Disc Disease (DDD) starts with the S 4 and S 4 Element systems that are recognized as one of the most comprehensive tabbed and tabless pedicle screw solutions available today. The ultra-low profile S 4 technology possesses excellent biomechanical strength and is compatible with specialty instrumentation, including S 4 SRI to address spondylolisthesis and S 4 FRI to treat fracture reduction needs, in a controlled and precise manner. 2

3 The S 4 Technology The S 4 and S 4 Element implants are engineered to maximize stability of the construct while providing intuitively designed instrumentation for ease in implantation. Both systems share an ultra-low profile, unique locking technology and excellent biomechanical strength as well as accommodating Open, Mini-Open or Percutaneous surgical approaches. S 4 Technology Design Advantages: Tabbed and tabless pedicle screws Small implant volume Pressure Vessel Technology Patented interlocking thread design Intuitive instrumentation Multi-level capability Specialized instrumentation S 4 S 4 Element aesculapimplantsystems.com/ddd 3

4 Anatomically Designed Technology Small Implant Volume Tabbed & Tabless Screw Offering S 4 extended breakway tabbed and S4 Element tabless screws are designed to have an ultra-low profile, minimizing interference with surrounding soft tissue and bony structures. S4 S4 Element Minimize Anatomical Impingement S 4 and S4 Element systems feature a facet sparing small screw head diameter for minimal anatomical impingement. S4 10.5mm screw head Maximize Range of Motion T he ultra-low profile design of S4 and S4 Element maximize screw head range of motion and simplify rod insertion due to low run on the rod. S4 range of motion 4 S4 Element 12.5mm screw head

5 Intuitively Designed Instrumentation T he self-registering external geometry of S4 Element screws ease engagement of instruments onto the screw body. Patented Interlocking Thread Design Minimizes splaying of screw body S4 Element screw threads Pressure Vessel Technology Pressure Vessel Achieved The S4 and S4 Element Spinal Systems feature a unique locking mechanism which creates a Pressure Vessel. This unique locking technology allows the S4 and S4 Element screws to maintain ultra-low profile with impressive biomechanics. The pressure vessel is achieved while torque is applied to lock the set screw and the screw body is drawn upwards into the smaller diameter hoop of the tulip head resulting in high interconnection strength. Pressure Vessel Biomechanical Testing Biomechanical testing for Axial Grip and Interconnection Fatigue on S4 and S4 Element demonstrate the strength of the Pressure Vessel locking technology. Axial Grip (N) Interconnection Fatigue (Nm) System 1* System 2* S4 Spinal System S4 Element System 3* System 4* 0 System 1* System 2* S4 Spinal System S4 Element System 3* 2.5 System 4* *According to information of manufacturer aesculapimplantsystems.com/ddd 5

6 Comprehensive Surgical Solutions Multi-Level Capability A broad selection of rod-to-rod connectors are available to extend an existing construct in the event of a revision surgery or for new multi-level cases. A variety of options in lengths and styles allow surgeons to choose intraoperatively the best fit for the patient s anatomy. Domino, axial and lateral offset connectors Variety of sizes and lengths Open or closed styles Specialized Instrumentation Only the S 4 System offers access to a unique set of specialty instrumentation designed to reduce spondylolisthesis or fractures using a posterior approach. S 4 SRI Reduction with a single level fusion, spares adjacent healthy vertebra Precise and controlled reduction maneuver lowers the risk of inadvertent or potentially damaging movements Scan to see the instrument in action S 4 FRI Distraction, reduction and curvature correction in all planes is accomplished with precision and control Unlike Schanz screws, the FRI technology is based off of a pedicle screw, making complex spine and revision cases easier through the ability to extend or revise the construct. S 4 SRI S 4 FRI 6

7 World-Class Education As the world s largest and one of the most respected manufacturers of surgical instruments, Aesculap provides best-in-class implants and instrumentation that are supported by world-class, customized education programs designed to fit surgeon needs with the goal of patient satisfaction in mind. The Aesculap Academy aims to provide a highly specialized training to fit individual practice and hospital needs. Customized programs can be built to meet your curriculum and location needs. A complete and innovative approach designed to further the science of Degenerative Disc Disease (DDD) treatment and provide the backbone for your surgical needs. Indications and Contraindications Indications: The S 4 and S 4 Element Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation), 4. Spinal Stenosis, 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor, 7. Pseudoarthrosis, and 8. Failed previous fusion. Contraindications: Contraindications of the S4 and S4 Element Spinal System are similar to other commercially available posterior spinal fixation systems of similar design and material. Contraindications include, but are not limited to, the following: 1. Use in the Cervical Spine 2. Active systemic or local infection 3. Obesity 4. Pregnancy 5. Mental illness 6. Severe osteoporosis or osteopenia 7. Metal sensitivity/ allergies to the implant material 8. Alcohol or drug abuse 9. Patients unwilling or unable to follow postoperative instructions 10. Neuromuscular diseases/ disorders 11. Soft tissue deficit not allowing wound closure 12. Any medical or physical condition that would preclude the potential benefit of spinal implant surgery. 13. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device. 14. Any medical or mental condition which would exclude the patient or put the patient at high risk from surgery of this severity. 15. For pedicle screw cases, inadequate pedicles of the fifth lumbar (L5) vertebrae. aesculapimplantsystems.com/ddd 7

8 All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA. Aesculap is an equal opportunity employer Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA Phone Fax Aesculap Implant Systems, LLC - a B. Braun company DOC1136 2M 5/14