Vertiflex

Vertiflex is a proven, minimally invasive solution for long-term relief from lumbar spinal stenosis leg and back pain.

This guide offers a detailed exploration of the Vertiflex procedure, a durable treatment that addresses the cause of your pain. The goal is to provide you with robust, evidence-based information on how Vertiflex works and who it can help. We will examine the data behind its long-term success and compare it to other treatments you may be considering.

In This Article

Key Takeaways

• Addressing the Root Cause of Pain: The Vertiflex procedure is a minimally invasive, mechanical solution that addresses the structural cause of lumbar spinal stenosis (LSS) pain. It works by implanting a small device that holds the vertebrae slightly apart, which mimics the forward-leaning posture that naturally relieves symptoms. This creates more space for the nerves without the surgical removal of bone or tissue.
• Intended for a Specific Patient Profile: The ideal candidate has a confirmed diagnosis of moderate LSS and experiences neurogenic claudication—leg or buttock pain that worsens with standing or walking but is reliably relieved by sitting or leaning forward. The procedure is considered after at least six months of conservative treatments, such as physical therapy or injections, have failed to provide lasting relief.
• Supported by Strong Clinical Evidence: The procedure’s effectiveness is supported by a five-year clinical trial. This study demonstrated significant and durable outcomes, including a 75% average reduction in leg pain, a 90% patient satisfaction rate, and an 85% reduction in the proportion of patients taking opioid medications at the five-year mark.
• Minimally Invasive with a Focused Recovery: The Vertiflex procedure is performed on an outpatient basis through a small, one-centimeter incision and does not require general anesthesia. While patients go home the same day, a successful outcome requires adherence to a six-week period of activity restrictions, which includes avoiding heavy lifting, deep bending, and strenuous exercise.
• Preserves Future Treatment Options: A primary advantage of the Vertiflex procedure is that it is completely reversible and preserves the natural anatomy of the spine. If the implant does not provide adequate relief or if the patient’s condition changes, it can be removed, leaving all future treatment options, including a more invasive laminectomy, available.

Understanding Your Pain: What is Lumbar Spinal Stenosis (LSS)?

Lumbar spinal stenosis is a degenerative condition that develops gradually over time, which is why symptoms often appear in people over the age of 50. The condition involves a narrowing of the spinal canal in your lower back, which puts pressure on the sensitive nerves that travel to your legs and pelvis. Understanding the basics of what is happening inside your spine is the first step toward finding an effective treatment.

A Simple Explanation: Why Your Back and Legs Hurt

The term “stenosis” simply means “narrowing.” In lumbar spinal stenosis, the tunnel-like spinal canal in your lower back becomes constricted, squeezing the bundle of nerves within it. This nerve compression may be the direct cause of the pain, numbness, cramping, and weakness you may feel in your lower back, buttocks, and legs.

The “Shopping Cart Sign”: How Leaning Forward Reveals the Problem

The key clinical feature of LSS is something called neurogenic claudication. This refers to pain in the buttocks or legs that is specifically brought on by standing upright or walking and is reliably relieved by sitting or bending forward. This unique pattern gives rise to the “shopping cart sign,” where patients find they can walk much more comfortably while leaning on a shopping cart or walker. When you stand straight, your spinal canal naturally narrows, increasing nerve compression; when you flex forward, the canal opens, creating more space and easing the pressure. This postural relief is a powerful diagnostic clue that shows how a change in posture can directly impact your symptoms.

What Causes LSS? The Sources of Spinal Narrowing

For most people, LSS is the result of age-related “wear and tear” on the spine. Osteoarthritis is the single most common cause. As the body tries to stabilize aging spinal joints, it can create bone spurs that grow into the spinal canal. Other common causes include the thickening of a major spinal ligament (ligamentum flavum hypertrophy), which can buckle into the canal, and the bulging or hardening of the intervertebral discs that cushion your vertebrae.

Your Journey So Far: When First-Line Treatments Aren’t Enough

For nearly everyone with lumbar spinal stenosis, the treatment path begins with conservative, non-surgical approaches aimed at managing symptoms and improving function. If you are exploring more advanced options, it is likely because these initial therapies have not provided the durable relief you need.

The Limits of Physical Therapy and Medications

Physical therapy, which focuses on strengthening core muscles and improving posture, is a cornerstone of conservative care. Medications like NSAIDs or nerve pain modulators can also help manage symptoms. While these methods can be effective for milder cases, they often fail to provide adequate relief for moderate LSS because they do not change the underlying structural narrowing that is compressing the nerves.

Steroid Injections and Nerve Blocks: A Temporary Fix

When pain persists, a Selective Nerve Root Block (SNRB) or other epidural steroid injection is often the next step. This procedure involves injecting a powerful anti-inflammatory steroid around the specific nerve root that is causing your pain. While these injections can be very helpful for confirming the source of your pain and providing temporary relief for weeks or months, they are ultimately a chemical treatment for a symptom (inflammation). Because the physical narrowing remains, the inflammation and pain often return once the steroid wears off, creating a cycle of repeat injections.

The Vertiflex Procedure: A Structural Solution for Lasting Relief

When temporary treatments no longer provide sufficient relief, the focus can shift to a durable solution that addresses the underlying problem. The Vertiflex™ Procedure is a minimally invasive, FDA-approved treatment designed to provide long-term relief by correcting the structural issue causing LSS pain. It was developed to fill the gap between temporary injections and major open surgery, offering a new level of care for patients with moderate LSS.

How Vertiflex Works: Creating Space to Relieve Nerve Pressure

The Vertiflex procedure uses a small, H-shaped titanium alloy implant called the Superion® Interspinous Spacer. The genius of the implant is its simple mechanical principle: it acts as an “extension blocker.” Once placed between the spinous processes (the bony protrusions you can feel in your back) it physically prevents the vertebrae from moving too close together when you stand up. This action holds that part of your spine in a slightly flexed position, directly mimicking the posture that gives you relief when you lean on a shopping cart. This is called indirect decompression; by keeping the bones slightly apart, the implant enlarges the spinal canal and lifts pressure off the nerves without any surgical removal of bone or tissue.

What to Expect on Procedure Day: A Minimally Invasive Experience

The Vertiflex procedure was designed to be significantly less invasive than traditional spine surgery. It is performed on an outpatient basis, meaning you can go home the same day. Instead of general anesthesia, it is typically done with a local anesthetic and moderate intravenous (IV) sedation, often called “twilight sleep,” to keep you comfortable.

Your doctor will make a tiny incision, about one centimeter, and use a series of small dilators to gently separate the back muscles rather than cutting them. Using live X-ray guidance, the folded spacer is positioned correctly and its “wings” are opened to secure it in place, after which the incision is closed with a single stitch or adhesive strip.

The entire process is quick, taking only about 15 to 30 minutes for each spinal level being treated.

Is Vertiflex Right for You? Identifying an Ideal Candidate

Successful outcomes with the Vertiflex procedure depend heavily on careful patient selection. Your physician will use a specific set of criteria based on extensive clinical data and FDA guidelines to determine if you are likely to benefit. Thinking about your own symptoms and treatment history can help you prepare for a conversation with your doctor about your candidacy.

Key Signs You Might Be a Good Candidate for Vertiflex

You may be an ideal candidate for the Vertiflex procedure if you have a confirmed diagnosis of moderate LSS and your symptoms align with those successfully treated in clinical trials. Consider if the following statements apply to you:

• My leg, buttock, or groin pain clearly gets worse when I stand or walk for a period of time.
• I feel significant and reliable relief from my symptoms when I sit down or lean forward on something like a shopping cart.
• I have already tried conservative treatments like physical therapy, medications, and steroid injections for at least six months, but they have not provided lasting relief.

Who Should Not Consider the Vertiflex Procedure?

The procedure is not recommended for all patients. The primary contraindications include an allergy to titanium or its alloys. It is also not advised for patients with severe spinal instability, such as a spondylolisthesis (vertebral slippage) greater than Grade 1, or those with severe osteoporosis or an existing fracture of the spinous process.

The Evidence for Vertiflex: A Look at Proven, Long-Term Results

When considering any medical procedure, it is important to look at the quality of the clinical evidence supporting its safety and effectiveness. The Vertiflex procedure is backed by a robust body of data, including a Level 1 Randomized Controlled Trial—the highest standard of clinical study. This trial was the largest FDA device study ever conducted for LSS and followed patients for five years, providing crucial long-term data on the procedure’s durability.

Five-Year Clinical Trial Data: Durability, Pain Relief, and Satisfaction

The results from the five-year clinical trial demonstrate that Vertiflex provides significant and sustained benefits. At the five-year mark, patients experienced a 75% average improvement in leg pain and a 66% average improvement in back pain. Function also improved dramatically, with 81% of patients showing success in the physical function domain of a standard LSS questionnaire.

Crucially, the high level of relief led to 90% of patients expressing satisfaction with the procedure after five years, and 75% of patients were able to avoid a more invasive surgery at the treated level for at least five years.

A Life with Less Pain: Real-World Benefits and Reduced Opioid Use

Beyond the numbers, these results translate into meaningful improvements in daily life. The structural relief provided by the implant is effective enough that the five-year study documented an 85% reduction in the proportion of patients taking opioid medications. This “five-year window” of improved health can delay or even prevent the need for a much more invasive surgery like a laminectomy. For many, this period of sustained quality of life is invaluable.

Vertiflex vs. Other LSS Treatments: A Clear Comparison

Making an informed decision requires understanding how the Vertiflex procedure fits in with your other treatment options. It occupies a strategic space between temporary interventions and major surgery, but it has key differences from other minimally invasive procedures as well.

Vertiflex vs. MILD Procedure: Which Is Better for Your Stenosis?

The MILD (Minimally Invasive Lumbar Decompression) procedure is another excellent treatment for LSS, but it works differently from Vertiflex.

The MILD procedure is a subtractive treatment; it works by removing a small amount of the thickened ligament that is causing nerve compression, leaving no implant behind. In contrast, Vertiflex is an additive treatment; it adds a spacer and does not remove any tissue.

While MILD is ideal for stenosis caused primarily by ligament thickening, Vertiflex may address a broader range of stenosis causes. And, unlike MILD, Vertiflex is typically not used at the L5-S1 spinal level due to anatomy.

Vertiflex vs. Laminectomy (Open Surgery): Weighing Invasiveness and Recovery

For severe LSS, a decompressive laminectomy has long been the definitive surgical treatment. This open surgery involves a large incision, cutting the back muscles, and removing a portion of the vertebra to create more space.

Vertiflex offers a stark contrast as a muscle-sparing procedure performed through a tiny incision with a much faster recovery period of weeks, not months. Perhaps the most crucial difference is that a laminectomy permanently alters the spine, while the Vertiflex procedure is completely reversible.

Life After the Vertiflex Procedure: Recovery and Long-Term Outlook

Understanding the recovery process is key to setting realistic expectations and achieving the best possible outcome from your Vertiflex procedure. While many patients report feeling significant pain relief very quickly, it is important to remember that your body needs time to heal properly. Therefore, following your physician’s post-procedure instructions is critical to a successful long-term result.

The First Six Weeks: Following Activity Guidelines for the Best Outcome

After your outpatient procedure, you will be given specific instructions for the first six weeks to allow the implant to settle and the surrounding tissues to heal. It is normal to have some soreness at the incision site, which can be managed with ice and over-the-counter pain relievers.

During this initial healing phase, you must avoid any lifting of objects heavier than 10 pounds, as well as deep bending at the waist or significant twisting of your spine. Strenuous activities like running, golfing, or swimming are also restricted during this time. However, light activity, especially walking, is encouraged and can be gradually increased as you feel comfortable.

Beyond Recovery: Returning to Activities and Staying Healthy

After the initial six-week healing period, you can typically begin to resume your normal activities gradually. Your doctor may recommend a course of physical therapy to help you safely regain strength, flexibility, and confidence in your movements.

Patients who commit to an ongoing program of core strengthening and regular exercise often achieve the most durable long-term results. It is also essential to always inform any medical or imaging staff that you have a Vertiflex implant before undergoing an MRI or any other procedure in the future.

FAQs

Conclusion

Living with the pain of lumbar spinal stenosis can be agonizing. The Vertiflex procedure offers a clinically proven, minimally invasive treatment that can address the root cause of your pain. It provides a durable, structural solution that goes beyond the temporary relief of injections but avoids the risks and long recovery of major surgery, while keeping your future options open.

Novus Spine & Pain Center

Novus Spine & Pain Center is in Lakeland, Florida, and treats patients with chronic pain with numerous therapies, including Vertiflex. By using a comprehensive approach and cutting-edge therapies, we work together with patients to restore function and regain an active lifestyle while minimizing the need for opiates.

For your convenience, you may schedule an appointment online, request a call back, or call our office at 863-583-4445.

Resources for Additional Research

• Clinical Data on the Vertiflex™ Procedure (Boston Scientific)
• Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis (NIH)
• Vertiflex Improves Quality of Life in Military Veterans Suffering from Low Back and Leg Pain (LSU Health)
• Treating Lumbar Spinal Stenosis With Vertiflex Interspinous Spacer: A Single-Center, Independent, Retrospective Review (Neuromodulation Journal)
• Interspinous Spacers (Novus Spine & Pain Center)