ROI-A® ALIF Cage

With VerteBRIDGE Plating® Technology

1000x1000_insetimage_ROI-A

ROI-A® is a novel system designed for zero-profile,stand-alone* anterior lumbar interbody fusion. The ROI-A ALIF cage features a large central graft space and is available in a variety of footprints, heights, and angles of lordosis to achieve excellent fit and fill in diverse patient anatomy. The cage accommodates self-guided, self-locking VerteBRIDGE® plating designed to provide stability with no instrumentation protruding anterior of the vertebral bodies.

The self-guided, curved VerteBRIDGE plating is delivered in the plane of the disc through a direct anterior approach, so that the surgery can be achieved with less exposure than may be required to implant contemporary stand-alone systems with screws that must be inserted at oblique and challenging angles. The implant holder facilitates optimization of the anterior-posterior position of the implant, provides soft tissue retraction, and protects vascular structures during insertion of the VerteBRIDGE plating.

* In cases of spondylolisthesis or vertebral instability, the ROI-A implant should be augmented with additional anterior or posterior supplemental fixation.
  • Multiple footprints, lordosis, and heights as well as three plate lengths for optimized fit and stability in various patient anatomy
  • Optimized cage shape for peripheral coverage of the endplates and strong support on cortical bone
  • Tapered posterior shape to ease insertion
  • Large central graft space
  • PEEK-Optima® material for biocompatibility and radiolucency and Tantalum markers for verification of cage positioning.
  • Novel stand-alone technology*
  • Zero-profile design with no hardware protruding anterior of the vertebral bodies
  • Self-locking plates designed for initial and long-term stability
  • Anterior mini-open technique for insertion in the transverse plane
  • Adjustable anterior-posterior placement prior to insertion of the plate
  • Self-guided, curved plates ease insertion
  • Inserter provides protection of vascular structures during plate placement

 

*In cases of spondylolisthesis or vertebral instability, the ROI-A implant should be augmented with additional supplemental fixation.

Indications for Use (United States)

The ROI-A ALIF Cage 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 or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 supplemental fixation and with autograft to facilitate fusion.

Contraindications

Contraindications include, but are not limited to:

  • Presence of fever or acute, chronic, systemic, or localized infection.
  • Metal sensitivity or allergies to the implant materials, documented or suspected.
  • Severe osteopenia.
  • Pregnancy.
  • Prior fusion at the level(s) to be treated.
  • Patients unwilling or unable to follow post-operative care instructions.
  • Other medical risks, anesthetics risks, or surgical conditions which would preclude the potential benefit of spinal implant surgery.
  • Any condition not described in the indication of use.

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 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 steel 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. Internal fixation devices such as rods, connectors, screws, hooks, etc., which come into contact with other metal objects must be made from like or compatible metals. This is an important consideration when using supplemental fixation, as required by the indications for use of the System. Because different manufacturers employ different materials, varying tolerances, manufacturing specifications, and differing parameters, components of the ROI-A ALIF Cage should not be used in conjunction with components from any other manufacturer's implant systems. Any such use will negate the responsibility of LDR Spine USA for the performance of the resulting mixed component implant.
  • Any decision by a surgeon to remove the implanted 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

Precautions

  • Being a technically demanding procedure presenting a risk of serious injury to the patient, the implantation of intervertebral body fusion devices or partial vertebral body replacement devices should be performed only by experienced spine surgeons with specific training in the use of this system and who have knowledge of the present instruction for use.
  • The surgeon should consider the location of implantation, the weight of the patient, the patient's activity level or general conditions and any other factor which may have an impact on the performance of the system.
  • Patients who smoke have been shown to have an increased 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., substantial walking, 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 the implantation that they may substantially decrease the expected useful life to the device. 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 such spinal surgery. Knowledge of surgical techniques, proper reduction, 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. (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants.)
  • Supplemental internal fixation is required when using the ROI-A ALIF Cage. The VerteBRIDGE Plate system is available for use with the ROI-A ALIF Cage and is the supplemental fixation available for use in situations where a stand-alone construct is appropriate. The system may be augmented with additional supplemental fixation, as needed and determined by the user. The instructions for use for any additional supplemental fixation system(s) should be followed according to the manufacturer's guidelines.
  • Care must be taken to protect the components from being marred, nicked or notched as a result of a 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.
  • Sale of this product is restricted to physicians.

MR Safety Information

  • Non-clinical testing has demonstrated that the Interbody Cage Systems are MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:  MRI system.
  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T) only.
  • Maximum spatial gradient field of 3100 G/cm (31 T/m) for 1.5T Systems and 1500 G/cm (15T/m) for 3.0T systems
  • Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of
    • 2.0 W/kg for 15 minutes of scanning at 1.5T.
    • 2.0 W/kg for 15 minutes of scanning at 3.0T.
  • When other methods of supplemental fixation are used, also follow the MR conditional labeling for the additional components.
  • Under the scan conditions defined above, the ROI-A Implant System is expected to produce a maximum temperature rise of less than 1°C after 15 minutes of continuous scanning.
  • In non-clinical testing, the image artifact caused by the device extends approximately 1.0cm from the ROI-A ALIF Cage when imaged with a gradient echo pulse sequence in either a 1.5T or a 3.0T MRI system. 

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.