Technology - LT-CAGEŽ Lumbar Tapered Fusion Device
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS
The LT-CAGEŽ Lumbar Tapered Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. LT-CAGEŽ devices are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the LT-CAGEŽ Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the LT-CAGEŽ device. The LT-CAGEŽ Lumbar Tapered Fusion Device should not be implanted in patients with an active infection at the operative site or with an allergy to titanium or titanium alloy.
The laparoscopic surgical approach is associated with a higher incidence of retrograde ejaculation, malpositioned implants, anatomic difficulties, and conversion to open surgical approach.
The safety and effectiveness of the LT-CAGEŽ Lumbar Tapered Fusion Device have not been established in patients with any of the following conditions: spondylolisthesis or retrolisthesis of Grade II or greater; more than one level to be fused; revision of previous interbody fusion procedures; postoperative steroidal or nonsteroidal anti-inflammatory medication requirements; gross obesity; ages less than 18 years or greater than 65 years; osteoporosis, osteopenia, and/or osteomalacia; and pregnancy. Some of the potential adverse events which may occur with the device are as follows: disassembly of components; foreign body (allergic) reaction; tissue or nerve damage; post-operative change in spinal curvature, loss of correction, height, and/or reduction; infection; dural tears; both neurological and urological system compromise; scar formation; bone fracture; non-union (or pseudarthrosis), delayed union, mal-union; cessation of any potential growth of the operated portion of the spine, loss of spinal mobility or function; graft donor site complications; damage to blood vessels and cardiovascular system compromise; gastrointestinal complications; reproductive system compromise (including retrograde ejaculations in male patients), damage to internal organs and connective tissue; development of respiratory problems; incisional complications; insufflation complications; change in mental status; death.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician with appropriate training or experience.
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of degenerative disc disease (DDD), and other important medical information.
It is important that you discuss the potential risks, complications, and benefits of LT-CAGEŽ Lumbar Tapered Fusion Device with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.
Incorporates technology developed by Gary K. Michelson, M.D.