Avenue® L Lateral Lumbar Cage

With VerteBRIDGE Plating® Technology

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The Avenue L Lateral Lumbar Cage is designed for strength, versatility, and stability. It represents the pinnacle of lateral lumbar cage evolution incorporating zero-profile, intradiscal, and integrated fixation. The enhanced in-line, self-guided VerteBRIDGE Plating Technology facilitates simplified cage insertion all through a direct, minimally invasive approach.

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  • Comprehensive offering of footprints to meet different patient anatomy and provide for optimal endplate contact
  • Beveled nose to ease insertion
  • I-beam design to increase the rigidity of the cage and support the graft during insertion into the intervertebral space
  • Intra-operative adjustment of the Cage Holder to ensure optimal positioning of the cage prior to insertion of VerteBRIDGE plating
  • Guided in-line plate delivery
  • Sterile packaging for assured product quality and absolute traceability
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  • Zero-profile design with no hardware protruding anterior of the vertebral bodies
  • Self-locking plates designed for initial and long-term stability
  • Self-guided, curved plates ease insertion
  • Inserter provides protection of vascular structures during plate placement
  • Innovative plate delivery system optimized for the direct lateral approach
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INDICATIONS FOR USE

The Avenue L Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft to facilitate fusion.

CONTRAINDICATIONS

  • Cardiac problems.
  • Abuse of medicine, drugs, tobacco or alcohol (which change the ossification power).
  • Bony abnormalities preventing safe anchoring plate fixation.
  • Material sensitivity documented or suspected.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in post-operative care.
  • Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and or fixation to the implant.
  • Obesity can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.
  • Recent infection, fever or hyper-leukocytosis.
  • Open wounds.
  • Bone absorption, osteopenia and/or osteoporosis.
  • Patients having inadequate tissue coverage over the operative site.
  • Pregnancy.
  • Excessive local inflammation.
  • Other medical (for example : anesthetics risks) or surgical conditions which would preclude the potential benefit of spinal implant surgery such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases.
  • Major spinal instabilities
  • Degenerative spondylolisthesis grade II or more

WARNINGS

  • Risks associated with general surgery, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery. It is also recommended that the advantages and disadvantages of surgery, the implants, as well as alternative treatment methods be explained to the patient.
  • Potential risks associated with the use of this system, which may require additional surgery, include device component failure (bending, loosening or fracture), loss of fixation, non-union, fracture of the vertebra, neurological injury, vascular or visceral injury, neurological complications, over-distraction, trauma to nerve root or dura, incorrect implant positioning, implant migration, pseudoarthrosis, disc height loss (impaction of implant into vertebral end plates), allergy or inflammation, general adverse effects related to surgical procedures (e.g. anesthesia, infection), subsidence, expulsion.
  • The device can break if it is subjected to increased loading associated with delayed union or non-union. If healing is delayed or does not occur, the implant could eventually break due to material fatigue. Factors such as the patient weight, activity level, and compliance to weight bearing or load bearing instructions, have an effect in the stresses to which the implant may be subjected, and may affect the longevity of the implant.
  • Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery
  • Discard all damaged or mishandled implants.
  • Under no circumstances may the implants be re-used. Although the device may appear intact on removal, internal modification due to the stress and strains placed on it, or small defects may exist which may lead to fracture of the implant.
  • Implants removed from a patient that contact bodily tissues or fluids should never be reused at risk of contamination of the patient.
  • Mixing Metal: Some degree of corrosion occurs on all implanted metal and alloys. Contact of dissimilar metals (e.g. stainless steels and titanium), however, may accelerate this corrosion process. The presence of corrosion may accelerate fatigue fracture of implants and the amount of metal compounds released into the body system may also increase.
  • Manufacturers employ different materials, manufacturing specifications and differing design parameters. Components of the Avenue® L Interbody Fusion System should not be used in conjunction with components from any other manufacturer.
  • Any decision by a surgeon to remove the device should take into consideration such factors as the risk to the patient of the additional surgical procedure as well as the difficulty of removal.
  • Implant removal should be followed by adequate postoperative management to avoid fracture.
  • Before implanting the Avenue L lateral thoracolumbar cage, the vertebral plates must be carefully prepared, being careful not to weaken the cortical bone to avoid implant subsidence.
  • The setting and possible repositioning of the Avenue L lateral thoracolumbar cage must be done with the cage holder attached to the cage.
  • In order to ensure its stability in the intervertebral space, the Avenue® L implant must be used with a supplemental internal fixation system (plate and/or screws type).
  • Do not attempt to reposition the implant after anchoring plates have been deployed into the vertebral endplates
  • The Avenue L Interbody Fusion System has not been evaluated for safety and compatibility in the MR environment.
  • The Avenue L Interbody Fusion System has not been tested for heating or migration in the MR environment.

PRECAUTIONS

  • Being a technically demanding procedure presenting a risk of serious injury to the patient, the implantation of intersomatic systems should be performed only by experienced spine surgeons with specific training in the use of this system and who have knowledge of the present instructions for use.
  • Based on fatigue testing results, when using the Avenue L Implant System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  • Patients who smoke have been shown to have an increased incidence of non-unions. Such patients should be advised of this fact and warned of the potential consequences.
  • If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g., running, lifting of significant loads, or muscle strain), resultant forces can cause failure of the device.
  • In some cases, progression of degenerative disease may also be so advanced at the time of implantation that they may substantially decrease the expected useful life to the implant. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.
  • Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the system. This device is recommended for use only by surgeons familiar with preoperative and surgical techniques, cautions and potential risks associated with spinal surgery. Knowledge of surgical techniques, selection and placement of implants, and pre and post-operative patient management are considerations essential to a successful surgical outcome.
  • Patients should be instructed in detail about the limitations of the implants, including but not limited to the impact of excessive loading through patient weight or activity, and should be taught to govern their activities accordingly.
  • Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life.
  • Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.
  • Inspection and trial assembly are recommended prior to surgery to determine if the instruments have been damaged during storage or prior procedures.
  • After any surgery, it is necessary to check the proper position of the implants and to follow the evolution of the fusion using appropriate techniques.
  • For the anchoring plates, it is imperative to respect the following points:
    • During multi-level implantations, care should be taken in plate size selection to minimize the possibility of adjacent plate interference.
    • Ensure the cage does not protrude proximally outside the intervertebral disc space to be sure that the anchoring plates are properly positioned in the vertebral body.
    • Prior to implanting the posterior construct, use fluoroscopy to verify the trajectory of the anchoring plates to avoid impingement with pedicle screws.
    • If there is potential for the plates to contact pedicle screws, it may be necessary to change the trajectory of the screws.
    • Very hard or sclerotic bone on the vertebral endplates can cause difficulty seating the VerteBRIDGE plate. If difficulty is encountered during plate impaction, the plate should be removed. Do not impact VerteBRIDGE with excessive force.
  • Sale of this product is restricted to physicians. 

Legal Manufacturer:

LDR Médical
Parc d’entreprises du Grand Troyes
Quartier Europe de l’Ouest
5 rue de Berlin
10300 Sainte-Savine, France


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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.