Thursday, October 22, 2009

Vertos: Is This an Illusion, or am I losing my Mind?

Recently, Vertos announced that it had completed $15.5 million in Series D financing. A tremendous achievement in this economy and a testimony to the management team. But STOP right there, before we go any further based on their website video TSB must ask the $15.5 million dollar question; "What's the benefit of this procedure?"

After many years in the industry and spending many days in surgery and spine conference it was always my understanding that lumbar spinal stenosis was attributed to a collapsed or herniated disc. If our readers agree with this observation, how many of you have ever seen a CT where a herniated ligamentum flavum was the cause of stenosis? If a surgeon removes the ligamentum flavum and lamina isn't the disc still cooking?

Most patients that present with pain usually have nerve root compression. The conpression on the nerve root is usually emanating pain as a by product of the herniated disc not because of a herniated ligamentum flavum. Am I missing something here? Patients' are usually treated conservativelywith steroid injection, pain medication and bed rest. How many of the estimated 900,000 lumbar spinal stenosis sufferers are candidates for this procedure? Why not have a discectomy and get it over with since the size of the approach is thumb size?

One of my colleagues and I were discussing this technology and both of us agreed that an investment of a few million might be worthy, but $15,5mm? TSB speculates that these investors were either sold a bill of goods, or they know something that we don't after being so many years in this business. TSB must laud the Vertos team for one thing, they were able to get a billing code for this procedure! TSB wants to know what our readers believe and think? If there are any surgeons reading our blog, we would welcome your opinions.

6 comments:

  1. Perc disc have been around for several years (15+). They're challenging and the positive outcomes are about 40% at best. Central disc herniations represent 95% of the offending pathology. How can you approach the central disc via a midline, 45 degree from prone technique? The last I checked my anatomy book below the lamina is the ligamentum flavum then the dura? How are they getting past the dura? I've been in the business for 20 years and NEVER seen a perc decompression of the lig flavum. Got any swamp land for sale?

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  2. First, XStop is indicated for central canal stenosis (due to ligamentum flavum thickening).
    As a disc loses height, the posterior elements lose height. The ligamentum flavum then rubs and buckles on itself. This causes scarring ang thickening, pressure on the dura.
    Imagine a football pressed against the dura. If you cut out one side, the other would draw back, thus decompressing. The flavum is never fully breached, except to put dye in the epidural space, creating an anterior border under imaging. Under fluoro you have 3 borders; the anter. dye line, the super lamina and infer lam. Like a soccer goal. Makes some sense on paper.
    I see 2 problems; Who can perform MILD? Spine surgeons don't have the imaging skills. IR's don't have the patient population and could alienate spine docs who refer to them. Pain generally can't get hosp priv to do it.
    The 2nd is, there is no way to address foramenal stenosis(think exiting nerve route)
    How often is there central stenosis without some lateral involvement.

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  3. DevRepper: Thanks for the excellent commentary. Your insight is greatly appreciated!

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  4. Devrepper is right. From the website of the AAFP: "In most cases, stenosis of the lumbar canal may be attributed to acquired degenerative or arthritic changes of the intervertebral discs, ligaments and facet joints surrounding the lumbar canal. These changes include cartilaginous hypertrophy of the articulations surrounding the canal, intervertebral disc herniations or bulges, hypertrophy of the ligamentum flavum and osteophyte formation." There are still others. In other words, the ideal patient -I mentioned the importance of patient selection for all these gizmos before, didn't I?- has an isolated hypertrophy of the ligamentum flavum. How often does that occur? One in 100.000, one in a million? Perform the MILD, and the spinal cord can bulge a little more freely posteriorly, which may give some relief, but also still may cause compression. Then, the renewed increase in instability will cause the facets and annulus and osteophytes to continue to grow and exacerbate existing, or cause new, symptoms. From Vertos' website: "In addition, most patients can decrease use of narcotics or pain medication at 6 weeks." Wow! Regression to the mean does exist! Seeing the video describe that MILD leaves the healthy ligamentous fibers intact(!), which of course conveniently are located closest to the canal, I get this incredible IDET itch. Yet another procedure a surgeon can add to the long line of options that he can offer to his patients, and that may do something for them (placebo?). But it certainly will make him money every time he does one, while not interfering with the next step in the therapeutic hierarchy. Spine, the gift that keeps on giving... Where does it end?

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  5. interesting comments. Vertos first approached the spine surgeons for selling this procedure and they did not have these patients, thus the company did a sweeping overhaul of management and went after the pain management community recognizing the uphill battle to getting the surgeons on board. There is another company that has a better product with a wider range of clinical application for stenosis called Baxano. The company sells a kit that includes an set of instruments that can be used for unilateral mild to severe stenosis. The vertos procedure is a bi-lateral procedure. The pain management physicians have some of these patients but the primary physicians have the majority of the patients. It will be interesting to see if reimbursement is affected with the changes in the new year and the fact that it is billed under a laminectomy code and is a disposable product.

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  6. After reading the comments above, I agree with all of them and my girlfriend works for Medtronic and we have discussed the mild versus the xstop and the fact that the xstop can be done on an out patient basis as well and under local sedation. I told her that the while that is true, the vertos, whether one agrees whether it works or not, is a direct decompression of the ligament which is causing the stenosis and the xstop is an indirect decompression of the ligament and also an implant. The marketing appeal of a procedure that leaves a small incision with no implants is driving a lot of their success right now along with the successful targeting of those physicians/surgeons who have the patients for the mild.

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