Ardis® Interbody System
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Uniquely tapered nose and convex shape allow for easy, atraumatic
insertion and maximize endplate contact
- A wide variety of sizes which allow for TLIF or PLIF approaches and ensure a customized fit to patient anatomy
Delivering enhanced interbody design. On the nose.
| Ardis is a self-distracting posterior interbody that is designed to facilitate efficient, versatile and reproducible fusion procedures. The name Ardis, Greek for “point of an arrow,” well-suits this system whose implant has a “double-bulleted” nose providing for an easier insertion. This multipurpose PEEK-OPTIMA® implant can be used in a variety of surgical approaches including TLIFs and PLIFs and is ideal for open, mini-open or MIS techniques. Ardis, which comes in 30 sizes and has a convex shape, facilitates a conforming and individual fit to the patient. The system also features low-profile and glare-resistant instrumentation that allows for excellent visibility during any procedure, regardless of the approach. A threaded inserter with a secondary knob for an enhanced instrument/implant connection gives the surgeon more precision, control and confidence during implantation. |
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Ardis Features
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Indications
The Ardis System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. Patients should be skeletally mature and have had six months of nonoperative treatment. The Ardis System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Contraindications
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Disease conditions which have been shown to be safely and predictably
managed without the use of internal fixation devices are relative
contraindications to the use of these devices.
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Active systemic infection or infection localized to the site of the
proposed implantation are contraindications to implantation.
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Severe osteoporosis is a relative contraindication because it may prevent
adequate fixation of spinal anchors and thus preclude the use of this or
any other posterior spinal instrumentation system.
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Any entity or condition that totally precludes the possibility of fusion,
i.e. cancer, kidney dialysis or osteopenia, is a relative contraindication.
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Other relative contraindications include obesity, pregnancy, certain
degenerative disease, and foreign body sensitivity. In addition, the
patient’s occupation or activity level or mental capacity may be relative
contraindications to this surgery. Specifically, some patients may,
because of their occupation or lifestyle, or because of conditions such as
mental illness, alcoholism or drug abuse, place undue stresses on the
implant.
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Known patient sensitivity to device materials (PEEK OPTIMA®).
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Prior fusion at the level(s) to be treated.
- Any condition not described in the indications for use.
