Superion - Indirect Decompression System
Do you have spinal stenosis? Do you feel pain in your low back and/or legs that gets worse with standing and better with sitting? Do you feel yourself hunching forward on shopping carts to relieve the pain? Have been told major spine surgery is your only option?
Well, there is an alternative…and it’s called Superion®!
The doctors at the Ainsworth Institute are proud to offer this cutting edge, FDA-approved therapy to stop spinal stenosis in its tracks [1-3]. This remarkable procedure takes minutes to perform with very little recovery time.
Vertiflex and the Ainsworth Institute present Superion – a minimally invasive therapy for treating spinal stenosis
What is Spinal Stenosis?
Spinal stenosis is a painful condition whereby the spinal cord does not have the space it needs inside the spinal column. In essence, the spinal cord becomes compressed or squeezed by other parts of the spine taking up too much space – more importantly, they take up space meant for the cord to lie. Think of it as a subway car with too many people on it: the car is already full, but more people keep getting on. With each extra person getting on, the rider in the middle gets squeezed even harder to make room. Eventually, there is no more room and it becomes uncomfortable and painful unless the rider positioners him/herself in a certain way. In the case of the spinal cord, the body tries to position itself a certain way to make room for the extra passengers to make things less painful for the cord – this is usually hunching or bending forward.
The most common symptoms of lumbar stenosis (spinal stenosis of the low back) are:
THIS IS NOT THE X-STOP!
In a head-to-head study against the X-STOP®, the Superion® InterSpinous Spacer was found to be better in every category [1-2]
How Does Superion Work?
The Superion® InterSpinous Spacer (ISS) is designed and FDA-approved for the treatment of symptomatic spinal stenosis [4]. In comparison to extremely invasive spine surgeries like decompressions, laminectomies and fusions where large incisions are made, chunks of bone are removed, screws are implanted and the spinal cord is exposed, Superion is the total opposite – no big incisions, nothing is removed and the spinal cord is left completely untouched.
The key to treating Lumbar Spinal Stenosis (LSS) is creating space for the spinal cord and “allowing it to breathe.” When you bend/hunch forward or sit down, you are temporarily opening up those tight areas of the spine and taking pressure off the cord. When you stand up straight again, the pain comes right back because the pressure on the cord returns. The Superion ISS holds the space open, even standing up straight.
Think of the Superion ISS like a stent in the heart – a small device used to pry open a tight space and make it bigger. The spacer is inserted through a small tube called a “cannula” onto the OUTSIDE of the spine. When the spacer opens up, it holds the tight area of the open making room for the spinal cord without it feeling squeezed or compressed.
The entire procedure is reversible and leaves no scar tissue in or on the spinal cord itself. If you have been told you need surgery for LSS, you owe it to yourself to try the Superion ISS first.
Is Vertiflex Superion Effective?
In a prospective, multi-center, randomized controlled clinical trial, 120 patients with LSS were treated with the Superion ISS [1,2]. At 3-years, 76.8% of patients reported significant reduction in back pain, and 84.1% reported reduction in leg pain [3]. In every category studied, these patients reported improvements – physical function, satisfaction, disability and severity of symptoms. The study also found Superion to be superior to X-STOP®(Medtronic, Inc., Minneapolis, MN, USA) in every category – most importantly complication rate. While many surgeons in the mid 2000’s found X-STOP® to be quite useful, the failure rate over time and the incidence of the device moving raised serious concern and eventually led to its demise. The clinical trial showed the Superion ISS had all the benefits of the X-STOP® but without its weaknesses – the Superion stays put!
Given the obvious risks of major spinal surgery and the long, painful recovery time, the Superion ISS is a proven alternative with sustained pain relief. In a study by Lauryssen et al in 2015, the authors compared the Superion ISS treatment to decompressive laminectomy for the treatment of LSS [3]. The authors showed that Superior was AS EFFECTIVE AS SURGERY at 12- and 24-months! Remember, this procedure is reversible – surgery is not.
[1] Patel V, Nunley P, Whang P, et al. Superion® interspinous spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial, Journal of Pain Research. 2105;8:657-662.
[2] Patel V, Whang P, Haley T, et al. Superion Interspinous Process Spacer for Intermittent Neurogenic Claudication Secondary to Moderate Lumbar Spinal Stenosis: Two-year results from a randomized controlled FDA-IDE pivotal trial. Spine. 2015;40(5):275-282.
[3] Lauryseen C, Jackson R, Baron J. Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2015 [early online].
[4] Loguidice V, Bini W, Shabat S, et al. Rationale,design and clinical performance of the Superion® Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011;8(4):419–426.
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