Products & Implants

Products & Implants


coflex® Interlaminar Technology

 coflex<sup>®</sup> Interlaminar Technology

An Alternative for Patients Who Fail Conservative Treatment

The coflex® implant may be the answer for patients who fail conservative treatments such as rest, medication, brace treatment, physical therapy, acupuncture, or chiropractic care. Compared to the standard of care (fusion surgery), the coflex® Interlaminar Technology has demonstrated:

  • Shorter operating time and hospital stay
  • Quicker recovery
  • Faster and sustained pain relief
  • Greater mobility at treatment level
  • Natural movement at adjacent levels

Regulatory approvals vary by country. Therefore, we kindly ask you to contact the distributor in your region regarding availability of specific products, implants and / or instrumentation in your region. Please note that this presentation is not valid for Germany. If you seek information on grafts and implants available in Germany, please visit the Germany section on this website.

 coflex<sup>®</sup> Interlaminar Technology


  • Device Features

    • Titanium alloy that is biocompatible and x-ray visible
    • Crimping of wings for increased primary stability
    • Five anatomical sizes
    • Color-coded instrumentation

    Functionally Dynamic

    • Compressible in extension, allowing flexion
    • Increased rotational stability
    • Center of rotation close to spinal canal

    Protection of Posterior Elements

    • Stress reduction on facet joints
    • Maintenance of foraminal height
    • Large contact area for optimized stress distribution

    Ease of Use

    • Less invasive, tissue-sparing procedure
    • Easy and precise application

    The coflex® Interlaminar Technology Design

    The coflex device consists of a single, U-shaped component, made from medical-grade titanium alloy, a material with a long history of safe use in implantable orthopedic products. In clinical use, the “U” is positioned horizontally, with its apex oriented anteriorly and the two long arms of the “U” paralleling the long axis of the spinous processes. The bone-facing surfaces are ridged to provide resistance to migration.

  • Indications

    Radiographically confirmed moderate to severe stenosis, isolated to 1 or 2 levels, in the region of L1 to L5 in a patient with or without concomitant low back pain, including conditions such as stable grade 1 spondylolisthesis. Interlaminar stabilization is performed after microsurgical decompression of stenosis at the affected level(s). The coflex® implant may also be used in up to 2 lumbar motion segments adjacent to fused level(s).

    Contraindications

    Do not use the coflex® implant in cases of:

    • Any medical or surgical condition precluding the potential benefit of spinal surgery
    • Acute or chronic systemic, spinal or localized infections
    • Systemic and metabolic diseases
    • Obesity
    • Pregnancy
    • Dependency on pharmaceutical drugs, drug abuse, or alcoholism
    • Lack of patient cooperation
    • Foreign body sensitivity to the implant material
    • Spondylolisthesis greater than grade 1 or unstable spondylolisthesis
    • Scoliosis greater than 25 degrees
    • Significant osteopenia

    Safety precautions

    • Prior to use, thoroughly read these instructions for use and become familiar with the surgical technique.
    • Keep the instructions for use accessible to all staff.
    • The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. Proper surgical performance of the implantation is the responsibility of the operating surgeon.
    • The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrect operating techniques, the limitations of treatment methods or inadequate asepsis.
    • Under no circumstances may modular implant components from different suppliers be combined.
    • Each patient's record shall document the implant used (name, article number, lot number).
    • During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that the physician keeps the patient well informed about post-surgical behavioral requirements.
    • Damage to the weight-bearing structures can give rise to loosening, dislocation and migration, as well as other complications. To ensure the earliest possible detection of such catalysts of implant dysfunction, the implant must be checked periodically post operative using appropriate techniques.
    • Fracture of the coflex® implant wing may occur during preparation when the wings are bent open or during insertion when the wings are crimped.
    • Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created non-visible damage that could result in implant failure.
    • Never use implants if the packaging is damaged. An implant with damaged packaging might be damaged itself and thus may not be resterilized/used.
    • Never use implants that are past their expiration date without resterilizing.
    • Do not resterilize implants if they have been contaminated by blood or secretions.
    • If the device is resterilized, make sure the product is only packaged and sterilized by qualified or trained staff. Follow the general guidelines and aseptic principles when handling items to be sterilized or sterile items. Devices manufactured from different metals should be processed separately to avoid electrolytic action between the metals. The health care provider must validate that the steam sterilization cycle is effective in their facility since all steam sterilization chambers are unique.