Coflex® Interlaminar Stabilization®

The Coflex procedure is performed through a small, midline incision in the lower back that allows for a minimally invasive approach for treating your lumbar spinal stenosis. The Coflex implant:

• Is inserted directly following a surgical decompression by your spine surgeon
• Rests on laminar bone in between two vertebrae, where the “U” is closest to the spinal canal
• Maintains foraminal height and off-loads facets
• Allows the bones to move in a controlled manner, preserving natural motion
• Reduces trauma to your back, decreases the amount of blood loss during surgery, and allows for a shorter hospital or outpatient surgical center stay compared to fusion

Benefits vs. Decompression

Decompression is appropriate for many patients; however, in order for the surgeon to adequately decompress the spine, all bony and neural elements putting pressure on the spinal nerves causing the pain should be removed, which may cause the spine to become unstable. Your surgeon can implant the motion-preserving coflex device directly after a surgical decompression to help keep your spine stable.

In a European study, coflex was compared to decompression alone. The coflex device proved to extend the durability and sustainability of a decompression procedure out to two years. The coflex patients experienced:

• Superior composite clinical results (combination of 4 clinically relevant factors: disability improvement, neurological maintenance or improvement, no subsequent interventions, no device-related complications)
• Superior walking distance improvement (2.4x more compared to decompression alone)
• Superior foraminal and disc height maintenance (allowing nerves to exit the spinal canal freely)
• Significantly less epidural steroid injections post-surgery (decompression patients had 3.3x more)

*Clinical cases are unique and individual results may vary. Claims based on ESCADA data, published in Journal of Neurosurgery: Spine. Volume 28 Issue 4, April 2018. Data on file at RTI Surgical, Inc.

Benefits vs. Fusion

Fusion is appropriate for many patients; however, motion is lost at both the treated and adjacent segments, multiple pieces of hardware and bone graft are required, and the recovery process can be long and difficult. Your surgeon can offer Coflex as an alternative to fusion for moderate to severe lumbar spinal stenosis with <Grade I spondylolisthesis patients.

In a U.S. FDA study, Coflex was compared to pedicle screw fusion. The Coflex device proved to be a viable alternative treatment option compared to pedicle screw fusion out to 5 years, and results showed that coflex patients performed as good as if not better in all clinical measurements. The Coflex patients experienced:

• Leg and back pain relief (both immediately and long-term)
• Less time in the operating room, less blood loss, and fewer days in the hospital
• Faster relief of symptoms and quicker recovery (pain and function measurements)
• Maintenance of range of motion at both treated and adjacent segments

Clinical cases are unique and individual results may vary. Claims based on FDA PMA P110008, October 2012. Data on file at RTI Surgical, Inc.

Indications For Use

The Coflex Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex^® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Contraindications

The Coflex^® is contraindicated in patients with:

• Prior fusion or decompressive laminectomy at any index lumbar level.
• Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
• Severe facet hypertrophy that requires extensive bone removal which would cause instability.
• Grade II or greater spondylolisthesis.
• Isthmic spondylolisthesis or spondylolysis (pars fracture).
• Degenerative lumbar scoliosis (Cobb angle of greater than 25º).
• Osteoporosis.
• Back or leg pain of unknown etiology.
• Axial back pain only, with no leg, buttock, or groin pain.
• Morbid obesity defined as a body mass index > 40.
• Active or chronic infection – systemic or local.
• Known allergy to titanium alloys or MR contrasting agents.
• Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction.

Important Considerations on Implant Usage

As a patient, there is always potential risk in having surgery or getting a medical device. Usually these risks are rare. You should refer to the Coflex Patient Labeling for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving Coflex, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The Coflex surgery may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery. Although uncommon, the device could be removed if necessary.

FDA PMA P110008, October 2012. Data on file at RTI Surgical, Inc.