Is your LOWER SPINE
holding you back?

See if the LimiFlex Clinical Study is right for you

Do you struggle with pain, tingling, or numbness in your leg or hip when walking or standing? It may be spondylolisthesis and spinal stenosis – common conditions of aging that can make it difficult or impossible to do the activities you enjoy most. When medications and injections fail to provide lasting relief, surgery is often recommended.

If you are considering surgery for your lower spine, but are looking to avoid spinal fusion, you may qualify for a new clinical research study. The study is for the LimiFlex™ Paraspinous Tension Band, an investigational device used during surgery that helps stabilize the spine without fusing it, thereby preserving motion in the spine.

The LimiFlex device is currently being offered at select spine treatment centers through the LimiFlex Clinical Study.

Common Spine Conditions

Spondylolisthesis & Spinal Stenosis
As we age, our spine changes due to “wear and tear” from normal, everyday activities. Spine ligaments thicken and widen, spinal discs lose height, joints get bigger, and your bones may grow spurs.

With spinal stenosis, these changes cause spaces in the spine to narrow and press against spinal nerves. Many people with spinal stenosis also have spondylolisthesis, a type of instability where one spine bone “slips” forward over the one below.

Nerve pressure from these conditions can result in leg pain, tingling, or numbness that gets worse when walking or standing, and improves when sitting or bending forward.

What is Surgical Decompression & Fusion?
When medications and injections fail to provide lasting relief, a surgical procedure known as “decompression” is often recommended. This procedure involves trimming or removing the bones and soft tissue pressing against your nerves – thereby relieving pain at the source. However, removing bone increases spinal instability. To compensate for this, surgeons often use screws and implants to “fuse” together segments of the spine to help stabilize them, a process known as “spinal fusion.” Although spinal fusion helps keep the spine stable following decompression, it also eliminates natural motion between spinal bones, which can lead to further problems.

What is LimiFlex?

LimiFlex™ is a new, investigational device used during standard spinal decompression surgery. LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion in the spine.

LimiFlex does not involve any screws or bone grafts, which eliminate the natural motion between spine segments. Rather, LimiFlex is made of two spring-like titanium rods that are wrapped around the back of two spine segments – this provides stability to the spine while also allowing the spine to move in a controlled manner.

The LimiFlex device is placed following a standard decompression surgery, typically in less than 30 minutes.

Frequent Questions
Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.
Yes, the LimiFlex device has been used in more than 2,000 patients in Europe. However, within the United States, the LimiFlex device is considered investigational and is currently only available through the LimiFlex Clinical Study.
A total of 291 people will be chosen for the study at up to 30 US study centers. The study is for people who struggle with leg pain, tingling, or numbness caused by degenerative spondylolisthesis with spinal stenosis.
If you are chosen for the study, your insurance will be billed for any standard-of-care medical expenses. You will not be charged for the LimiFlex device or any tests or follow-up visits required specifically for the study. You may also be reimbursed for some travel costs associated with your study visits.
If you join the LimiFlex Clinical Study, your participation will last approximately 5 years. Following your LimiFlex procedure, you will return to your study doctor’s office for 4 follow-up visits over the first year, and will then return for 4 additional annual visits. These visits are an important part of the study, as they allow your study doctor to closely monitor your individual results and experiences.
As with all clinical studies, your participation is completely voluntary, and you may leave the study at any time without any effect on your future medical care.
To see if you might qualify for the LimiFlex Clinical Study, and to be referred to a study center in your area, the next step is taking the pre-screening questionnaire. Please click here to get started.

See If You Qualify

To see if you might qualify for the LimiFlex Clinical Study, and to get connected directly with your local study center to learn more, please take the questionnaire below.