Champlain Spine and Pain Management are leaders and pioneers in non-surgical pain management – we were the first clinic in New York State (outside NYC) to offer Vertiflex to our patients. The Vertiflex procedure is refining the treatment of lumbar stenosis. The Vertiflex procedure is an innovative minimally invasive XR-guided treatment designed to deliver long-term relief for people who suffers from neurogenic claudication due to lumbar stenosis. This is a great treatment option for people who have failed conservative treatment including physical therapy, pain medicine, spinal injections and who want to avoid surgery. This condition can be very painful and functionally debilitating. The Vertiflex Procedure can treat this painful condition sparing patients a more invasive lumbar surgery.
What is Lumbar Spinal Stenosis?
It is a very common condition that affects more than 14 million Americans most commonly found in patients over 60 years of age. It is caused by a gradual narrowing of the spinal canal in the lumbar spine. The narrowing which gets worse with extension of the spine typically seen during walking and standing compresses the spinal nerves which runs through the spinal canal. As a result, the patient will often experience difficulties with walking or standing and the symptoms are often relieved with sitting down or leaning forward. The narrowing can be caused by many factors including arthritic bony overgrowths of the lumbar facet joints, enlargement of the ligamentum flavum or a disc herniation. All these conditions can alone or together contribute to the narrowing of the lumbar spinal canal resulting in lumbar stenosis.
If left untreated, the symptoms of neurogenic claudication due to lumbar stenosis will gradually worsen meaning more severe and more frequent symptoms with decreasing functions.
What are the symptoms of lumbar stenosis?
The symptoms of lumbar spinal stenosis often include:
- Worsening pain or achiness in legs and low back while walking and standing
- Pain relief when sitting or bending forward
- Numbness or “tingling” feeling in your legs, calves, or buttocks
- Weakness and/or loss of balance
- Feeling of heaviness in the 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 (“Shopping Cart Syndrome”)
What is the Vertiflex Procedure?
- The Vertiflex Superion procedure is an FDA approved cutting edge minimally invasive treatment that address lumbar spinal stenosis (LSS) by placing an FDA Superion interspinous titanium alloy spacer to act as an extension blocker between the spinous processes of two adjacent vertebrae. It is the only interspinous spacer marketed in the U.S. It essentially restores the normal space between the vertebrae. The procedure does not involve removal of bone as you see with a surgical laminectomy. In fact, nothing at all is removed from the patient’s low back.
- The procedure is an outpatient procedure typically performed in about 15 minutes per lumbar level. While the procedure can be performed with just local anesthetics (numbing medicine) most patients choose to receive moderate to deep IV sedation (not general anesthesia). Of course, plenty of local anesthetics is still used regardless of the sedation option chosen by the patient. Then a small incision (one cm- less than ½ inch) is made and an undeployed appropriately sized Superion implant is then advanced under live XR to its correct position (posterior to the spinal canal). Under live XR the device’s arms will be slowly fully deployed and advanced against the posterior lamina to secure its placement and to obtain maximum reduction of the lumbar stenosis. The incision is so small that most of the time suture or skin staples are not needed, and steri strip adhesive will be used instead.
- The result is that patients can now experience safe and more comfortable movements without the need for more invasive spinal surgeries. This implant can provide patients with lumbar spinal stenosis with a similar level of relief that they feel when they are in a seated position. Superion comes in varying sizes, allowing your physician to select the right implant for each patient’s anatomy.
- When this procedure is complete, the implant will continue to act as a spacer that decompresses the spinal canal to relieve the pinched nerves that are causing discomfort. The Vertiflex Procedure is reversible, leaving all treatment options available in the future. It is performed at the Surgical Pain Center of the Adirondacks by one of our board-certified pain management physicians.
How effective is the Vertiflex Procedure?
The Vertiflex Procedure is effective for the appropriate patient. This treatment option was initially studied through the IDE study which is the largest FDA Lumbar Spinal Stenosis Device Trial Ever Conducted and it followed patients up to 5 years. This level-one evidence-based procedure is supported by data from patients who reported successful outcomes. The study showed the following results at the 5-year mark:
- 84.1% success in function and symptoms at 5 years.
- >70% reduction in leg pain at 5 years.
- 74.7% without reoperation at 5 years
- 89.8 % patient satisfaction at 5 years.
Another study published in the Journal Pain research in November 2018 showed an 85% decreased in use of opioids at the 5-year mark.
The bottom line: the Vertiflex procedure is redefining the treatment of LSS for patients. It provides patients with a clinically proven, minimally invasive solution that is designed to deliver both short term and long-term relief from the leg and back pain associated with Lumbar Spinal Stenosis. Results and recovery for each patient are always individualized and always different. The Vertiflex procedure is one of the very few procedures that has five-year data.
What are the Benefits of the Procedure?
The benefits of the Vertiflex procedure include:
- Minimally invasive procedure
- Reduced risk of infection because there is no open spine surgery
- Spine is not destabilized
- There is a high success rate
- No hospital stay is required
- No general anesthesia is required
How Do I Know if I am a Candidate for Vertiflex?
If you believe you might be a candidate for the Vertiflex Procedure, ask yourself the following questions:
- Do you experience pain or weakness in your back, buttocks, or legs when you stand or walk?
- Do you use a cane, walker, or shopping cart to move around more comfortably?
- Do you frequently need to lean or bend forward, or sit down to find relief?
- Do you want to find an alternative option to lumbar surgery?
If you answered yes to any of the three questions above, you may be a candidate for the Vertiflex Procedure. Call and schedule your consultation with one of our providers at 518-324-7246 (PAIN) to discuss whether the Vertiflex Procedure is the right fit for you
What can you expect after the procedure?
After the procedure, you can expect some soreness at your incision site. You may or may not have one or two sutures which would need to be removed 7 to 14 days after the procedure. You may experience mild to moderate discomfort for a couple of days. These symptoms are typically well managed with over-the-counter medicine or/and a 3-day course of a weak opioid.
Are there any restrictions after the procedure?
For 6 weeks following your procedure, limit all moderate to heavy lifting, deep bending, twisting, and strenuous activity including swimming, golf, tennis, racquetball, running and jogging. Light activity, such as walking, and activities of daily living are allowed as tolerated. Once the implant is placed, most patients experience rapid relief from their discomfort, and often the relief is experienced immediately after the procedure. Patients generally enjoy a rapid recovery time. Once the procedure is complete, your physician will review some post-operative guidelines and care instructions which will be given to you.
Do insurance companies pay for Vertiflex?
Medicare and Medicaid currently cover the cost of the procedure. Other smaller commercial plans also do cover this procedure and many insurances plans are being added on a regular basis. It is best to ask our doctors or staff at Champlain Spine & Pain Management to see if your insurance plan will cover the cost of this procedure.
Can I have an MRI after the Vertiflex Procedure?
Yes! Non-clinical testing has demonstrated that the Vertiflex procedure is MR Conditional. This mean that it is safe for you to receive the older (1.5T) and the newer model (3.0T) MRI.
Are there any risks associated with the Vertiflex Procedure?
The Vertiflex procedure complications are seldom experienced. Even though this is a minimally invasive procedure, there are some risks involved with any procedure including the Vertiflex procedure. There risks include:
- Infection—this is a very rare complication. The procedure is done a sterile operating room at our surgery center. Additionally, we treat every patient with IV antibiotic on the day of the procedure and we typically give our patients a 3-day course of antibiotics after the procedure to prevent infection.
- Bleeding. This is also a very rare complication. It is mostly a concern for patients who are anti-coagulated—those patients who are on blood thinner- and we will not be able to offer this procedure if you are not able to stop your blood thinner medication.
- Fracture: there is specific complication for the Vertiflex procedure, and it is a fracture of the small bone called the spinous process. This is a very rare complication, and oddly enough, it really has no negative outcomes. It is not a fracture that we treat or has ever been treated in medicine. It is a fracture that causes no real significant bad outcomes.
- Another specific risk: The implant can become dislodged or moved out of place.
How is Vertiflex different from the MILD procedure?
While the MILD and Vertiflex procedures help patients suffering with similar symptoms collectively known as neurogenic claudication caused by lumbar stenosis, they are different procedures which treat the stenosis in quite different ways. With the MILD procedure the enlarged ligamentum flavum is being “thinned out”. It is helpful for people who suffer from lumbar stenosis due to enlargement of the ligament flavum. Vertiflex is a different procedure as it addresses multiples causes of lumbar stenosis such as enlargement of the ligament flavum as stenosis due to disc herniation and bony overgrowth of the facet joints. In other words, Vertiflex can address more causes for the treatment of lumbar stenosis than the MILD procedure. However, unlike the MILD procedure Vertiflex is not able to address stenosis at the L5S1 level while the MILD procedure can. Another difference is that with MILD, there are no implant or device left behind as compared to the Vertiflex procedure. Both procedures typically take a similar amount of time to perform per level and they both require a similar level of anesthesia (not general anesthesia). They are both considered minimally invasive outpatient procedures. Please see our page on MILD procedure for additional information. These procedures do not lead to destabilization of the lumbar spine. And finally, both procedures do not limit your ability to have lumbar surgery later.
Another option for lumbar stenosis has traditionally been a surgical laminectomy. This is not considered to be a minimally invasive procedure and it requires general anesthesia. It consists of creating additional space in the spinal canal by removing bones from your spine (called the lamina). This can lead to destabilization of the spine which may require additional surgeries later such as fusion to stabilize the spine. Patients who have received the MILD or the Vertiflex procedure can still be candidate for laminectomy surgery. The opposite is typically not true. For this reason, Vertiflex and MILD procedures are viewed as the perfect middle ground between conservative treatments and invasive surgeries to treat chronic back pain and lumbar spinal stenosis (LSS.)