Vertiflex Procedure–Cutting Edge Care for Lumbar Spinal Stenosis

At Seaview Orthopaedics, we offer cutting edge care–the Vertiflex Procedure–for the treatment of moderate lumbar spinal stenosis. The Vertiflex Procedure uses a small implant (the Superion® Indirect Decompression System) that is placed inside the spine to help prevent reduction of the space when standing or walking. This provides relief by lifting pressure off the nerves to alleviate leg and back pain symptoms that often accompany the condition.

Developed with patient safety and comfort in mind, this FDA-approved, outpatient treatment aims to give those with lumbar spinal stenosis the freedom to get on with their daily lives, as it offers a significant reduction in symptoms and improves physical function.

The Vertiflex is a minimally invasive stand-alone interspinous process decompression (IPD) procedure. IPD involves implanting a device (or spacer), such as the Superion®, between the spinous processes, which are the thin, bony projections on the back of the spine.

What is the Superion® device?

The Superion®, a registered trademark of Vertiflex, Inc., is a device that provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis.

What is neurogenic claudication?

Neurogenic claudication is a symptom of lumbar spinal stenosis. It refers to leg symptoms encompassing the buttocks, groin, and anterior thigh, as well as radiation down the posterior part of the leg to the feet.

What is the Superion® device made of?

The Superion® device is made of titanium alloy.

What are the benefits of an IPD Procedure?

Once the Superion® device is implanted it creates more space for your spinal cord and nerves in your spinal column without removing any bone (as in a traditional laminectomy) and with less trauma to your muscles and ligaments.

The other added benefits are that it helps to preserve some spinal motion (unlike spinal fusion that permanently limits movement), there is less blood loss, and there is reduced risk for infection.

What is lumbar spinal stenosis?

Lumbar spinal stenosis is a gradual narrowing of the space in the spine where nerves pass through. The narrowing of the space can cause pinching on the nerves in the lower back which can result in an aching, dull back pain spreading down the buttocks and into the legs.

What causes lumbar spinal stenosis?

The most common cause of lumbar spinal stenosis is aging where normal wear and tear on the spine as we age causes changes in the spine. Other causes may include

  • Osteoarthritis
  • Inherited conditions, such as a small spinal canal or a curved spine
  • Tumors of the spine
  • Injuries
  • Paget’s disease (a disease that affects the bones)
  • Too much fluoride in the body
  • Calcium deposits on ligaments that run along the spine

What are the symptoms of lumbar spinal stenosis?

The symptoms of lumbar spinal stenosis often include

  • Pain while walking
  • Pain relief when sitting or bending forward
  • Numbness or “tingling” feeling in your legs, calves, or buttocks
  • Weakness and/or loss of balance
  • Aching, dull back pain spreading to your legs
  • Decreased endurance during physical activities
  • Pain, weakness, tingling and/or cramping in the legs, buttocks, and/or back (neurogenic intermittent claudication)
  • Using a cane, walker, or shopping cart to move around more comfortably

For most people, symptoms develop gradually over time and are often made worse by standing and walking.

Who is a candidate for the Vertiflex Procedure?

If you are experiencing any of these symptoms and/or your doctor has diagnosed you with lumbar spinal stenosis, you may be a candidate for the Vertiflex Procedure.

Who is not a candidate for the Vertiflex Procedure?

You would not be a candidate for the Vertiflex Procedure if you have or have had

  • Cauda equina syndrome (when the nerve roots in your low back are severely compressed, which can permanently affect your movement and sensation)
  • Significant weakness
  • Significant scoliosis (Cobb angle > 10 degrees)
  • Acute fracture of spinous process or laminae fracture
  • Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1-4)
  • Prior fusion or decompression at the index level
  • Severe osteoporosis (DEXA scan or equivalent) in the spine or hip that is more than 2.5 S.D.
  • Ankylosed segment at affected level(s)
  • An active systemic infection or infection localized to the site of implantation
  • An allergy to titanium or titanium alloy

What imaging tests are needed to confirm stenosis?

The imaging tests needed to confirm stenosis are MRI and X-ray.

How effective is the treatment?

Based on a study published in the Journal of Pain Research in November 2018, the researchers examined and characterized the opioid medication usage patterns among patients treated with stand-alone IPD through 5 years of postoperative follow-up. The primary analysis included all 190 patients randomized to receive the Superion® device. In a sub-group of 98 subjects, they determined opioid medication prevalence among subjects with a prior history of opioid use. The results indicated that between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids, and a decreased opioid medication usage was also observed among the sub-group of subjects with a history of opiates prior to entering the trial.

This finding extends previous results with IPD showing long-term sustained clinical improvements, a reduction in symptoms of neurogenic claudication and a decreasing requirement for revision surgery in this population.

Does the procedure provide long-term relief?

Yes, the Vertiflex Procedure is a simple and safe, minimally invasive treatment clinically proven for effective, long-term relief from the pain associated with lumbar spinal stenosis.

How is the procedure performed?

For the Vertiflex Procedure, a patient is positioned face down on his/her stomach, and a local anesthetic and/or general anesthesia is administered.
With the use of real-time imaging (fluoroscopic guidance), the surgeon makes one small incision in your lower back and implants the IPD spacer between two spinous processes (e.g., L4-L5). The surgical incision is then closed.

How long does the procedure take?

Generally, the procedure takes 15 to 45 minutes to perform depending on whether one or two spacers are implanted.

Are there any risks associated with the Vertiflex Procedure?

The risks associated with the Vertiflex Procedure include

  • The implant can become dislodged or moved out of place
  • Bone may settle around the implant, which is a common risk in people with osteoporosis
  • The spinous process can fracture when the IPD spacer is implanted
  • After implantation, the spacer may not provide adequate relief from pain and symptoms
  • You may need additional surgery to relieve pain and other symptoms

What can you expect after the procedure?

After the procedure, you can expect some soreness, and your incision site will have a few stitches or staples that should be kept clean and dry until the first follow-up visit, usually 7 to 14 days after having the procedure.

Are there any restrictions after the procedure?

For 6 weeks following your procedure, limit all lifting, bending, twisting, and strenuous activity including lifting anything over 10 pounds, swimming, golf, tennis, racquetball, running, jogging, or sexual activity.

Light activity, such as walking, is allowed, as tolerated.

What happens if lumbar spinal stenosis is left untreated?

If lumbar spinal stenosis is left untreated, it can worsen over time, leading to excessive narrowing of the spinal canal. This can cause constriction of the nerves that run down the back and into the legs, resulting in pain, discomfort, and limited mobility.

Contact Us

If you are interested in the Vertiflex Procedure for moderate lumbar spinal stenosis, please give Seaview Orthopaedics a call at (732) 660-6200 to schedule a consultation.