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Building a “Barricaid” for Back Pain – In-Depth Doctor’s Interview

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Jamal Taha, MD, Neurosurgeon at Advanced Neurosurgery, Inc., talks about a new way to treat back pain.

Interview conducted by Ivanhoe Broadcast News in 2024.

Bulging discs – it seems if you don’t have one, you will. Talk to me about that idea.

Taha: Discs are cushions between two vertebrae, and we’ve got a lot of them in the body. And they work as cushions to buffer any forces on our spine. And as time goes on, there’s wear and tear, and the discs become a little bit more- get weaker, and as they get weaker, there’s a content in the disc like- usually it’s like a jelly, but it’s really much harder than a jelly and there’s an outward covering. And then when that jelly-like material starts bulging out of the covering, that’s what’s a bulging disc is.

Is it true that if you don’t have one, you’re probably going to get one one day?

Taha: Yeah, that’s part of wear and tear.

How are they treated?

Taha: Not much for bulging discs really. A lot of us have bulging discs, probably, you and I as we’re speaking now have bulging discs. And most of them are asymptomatic, they don’t cause any problems. If they do, it’s usually just a little what we call arthritis in late-term. And we just treat it with some exercises and just being active.

What type of pain are people dealing with?

Taha: Bulging disc can cause a little back pain. The problem isn’t with bulging discs, the problem is when they get herniated. And what that means is now there’s a tear in that covering and the contents come out of their place, and that causes a problem because that causes inflammation and the nerve is there. It can put pressure on the nerve, and that’s what we call sciatica.

What options are there for people when it comes to herniated discs?

Taha: When they do that, most herniated discs will heal on their own. I would say 80, 90% do not need any kind of surgery. Usually, the first few days, any inflammatory medicines and just maybe muscle relaxants, a little bed rest, not bed rest in the sense of not doing anything, just taking it easy. And usually most of the time in a few days, the pain is gone in herniated discs. Sometimes it’s not, and we do more of exercises. We send them to physical therapy and do some core muscle exercises, some stretching exercises. Occasionally, we give some injections around the nerve to reduce the inflammation.

What is a lumbar discectomy?

Taha: Once the herniated disc does not heal and patients continue with sciatica, that’s when we consider a discectomy. So what we do is very simple. There’s pressure on the nerve. We remove the pressure of the nerve. That’s the major goal of the surgery. So imagine of a disc- imagine the disc is like a pillow. And there’s something inside the pillow and there’s a cover. There’s a tear in that cover, and the contents of that pillow start coming out. The nerve is there, it pushes against the nerve. And so when we go in, that part that’s pushing against the nerve, we remove that part, and then we gauge it away as much as we can, in order to reduce the chances of this herniation happening again. So a discectomy is a procedure where you remove a little of the disc. How little is a state of art. One of the problems we have is that when there’s a tear, if you remove too much of the disc in order to reduce the chances of the herniation coming back, if you remove too much of that disc, that increases the chances of back pain after surgery. So the sciatica is gone, but they come back and say, ”I’ve got more back pain than I had before surgery.”  And if you remove too little, there’s a good chance that the disc can herniate again and cause sciatica again, which is a very severe pain. So it’s a balance between taking too much out or too little.

Many times patients need another operation. What would you need?

Taha: Well, one of the problems with our surgeries that we do currently is that we have this tear. And this tear sometimes is a small tear that we ourselves as surgeons enlarge in order to take out enough disc material to take the pressure of the nerve. Sometimes the tear itself is a big tear also. And when I say small a tear, just to give you a little idea, if you take a pencil and you think of the eraser at the bottom of the pencil, anything bigger than that eraser is a big tear. Anything smaller is a smaller tear. So what happens in these cases is that we have no way of closing that tear. Believe it or not, people have tried to put sutures and all this stuff, they just do not hold. And we just rely on scar tissue. That’s why we try to gauge away enough disc so we can put up scar tissue there to form and that reduces the chances of the disc re-herniating. When the disc re-herniates because the scar tissue didn’t hold things and the disc went through it, then the options are either to do a discectomy again, same thing, go in and you uncover the disc and remove that fragment and remove more of the disc. But in the country, actually, about 50% of the reoperation involves a fusion. And regardless of whether you end up with a fusion, which is something usually we try to avoid in younger people, or whether you end up with a discectomy, the reoperation is not as smooth as the first surgery. First, there’s more risk, especially of leaking spinal fluid from a tear in the covering of the nerves because of the scar tissue. And the second thing is that statistically speaking, less people go back to work, there’s increased disability, there’s increased use of opioids and a higher dose of opioids with reoperations. So a reoperation isn’t as successful as the index surgery. So we really need to find a way to do our best in the first surgery, rather than rely, we can go back and do something.

How many of the patients need reoperation?

Taha: Well, the chances of the disc recurring that is a lot. Some articles say about 6%, some articles say about 20%, 25% but there’s been a clear association of the risk with certain factors, including age, whether a person smokes or not, diabetics. These are some of the things that- factors that increase the risk of free surgery, and of course, activity and all this stuff. But one of the biggest factors is also the size of that tear in the covering of the disc. If that size is big, as I told you, that risk actually gets pretty high, almost about 25-30%. As a matter of fact, 70% of the operations are reoperations on a big size tear. And if you take some categories of patients like somebody, let’s say, a young female, a 35, 40 years old, 45 years old with a large annular tear, she is at a 40% risk of needing another surgery.

How is a Barricaid go? What is this?

Taha: Well, it’s a very simple and ingenious device, really. It’s a plug. You’ve got a tear, you put in something, and it plugs it, simple as that. Sounds simple, but the engineering is pretty crafty, actually. And so it’s a little device where you have a tear and so it goes in that tear and then it flips up as a plug- as a mesh. And it just plugs it, very much like that.

Why is this better than other options?

Taha: Well, there aren’t really much options. There are no options. People have tried to suture. It’s- it doesn’t work. You can’t put enough sutures there. It doesn’t close as well because it’s not an elastic thing. So it doesn’t give way. You can’t patch it because the area you’re working in is through a scope like this. So it’s very small and people have tried to do that, that doesn’t work. We just rely on scar tissue. So there is really no option. And this is at the moment, the only option available for something like this other than just leaving it for scar tissue for it to decide.

What was your situation when your patient, Amber Dillard came to see you?

Taha: Well, a young person like her pretty active, and she had severe sciatica, very severe pain that she was down from the back, down the leg. And she had tried the conservative treatments that we mentioned. And so at that point, we discuss options and took her to surgery and fixed her. And this is done. And that’s the nice thing about, again, going back to the Barricaid. The nice thing about the Barricaid procedure is that does not add to your standard technique. So whether I’m applying it or I’m not applying it, I’m not doing anything extra. We do a minimally invasive discectomy, so the incision is usually a bot and inch, and we go in and apply a little tube that goes over where the disc is hidden by the bone, and under the microscope, we uncover the disc by drilling a little bit of the bone enough to be able to see the disc and the nerve. Once we do that, then we inspect to see if the disc is totally ruptured, fragments have come out and detached completely or whether they’re still connected to the parent disc. We inspect the area, we inspect how it had herniated, and then take that fragment out. And then we look at the tear and see if it’s a big tear, small tear. Even if it’s a small tear, sometimes you have to enlarge it yourself in order to get adequate amount of decompression of taking the pressure of the nerve. And as I said before, we have to decide a very fine balance between how much disc we remove versus how much we leave, given the fact that we remove too much, that increases back pain, we remove too little, there’s a big chance of recurrence. And then we rely on scar tissue to close that tear.

Will she need to be?

Taha: No. In her case, we were able to put Barricaid. We discussed it and it got approved by her insurance plan, which is great. And all we did at that point is once we took the pressure off, we didn’t have to remove a lot of discs at that point, keeping as much as possible in order to reduce any back pain in the future and things like this. You really need that cushion to start with. That’s how we were created. And so once we finished that part, her tear was pretty big. And so we went ahead and applied that plug, just like we discussed. And the nice thing about this is we didn’t have to do anything extra. The amount of work it takes more is maybe about 5-10 minutes more. That’s it. It’s not like you’re putting an additional hour. So about 5-10 minutes, you’ll be able to put that plug in without doing any additional work. It’s the same incision, same everything. And bring out, it’s an outpatient procedure. She went home the same day. And the nice thing about this is now that I know that there’s a plug, I’m a little bit feel better in allowing her to do a little bit more in the beginning rather than just tell her, “Hey, you really have to be careful and not do anything.” Of course, people have to be careful. I still tell them don’t go jumping, but I can allow them to do more. They return to work more. Actually, it has been found statistically that people who had the Barricaid, their return to work was much higher rate than people who did not have it. Probably because they can get up and do things faster. And not only that the rate was higher, but they returned faster to work.

So, theoretically, she should need to be a re-operator, like you’re saying?

Taha: Yes. Barricaid doesn’t stop it completely. It has been shown it gives you about an 80% reduction. It’s not 100%. And the reason it’s not 100% is that it can’t fill every single plug the same way because you can’t. And so there might be a little bit still around or something like this. But an 80% reduction is a very successful thing. So yes, it’s not 100%, but it reduces the need for another surgery or re-herniation by about 80%.

What is the cost of Barricaid compared to fusion and the operation time and recovery time?

Taha: I can’t give you exact numbers because I’m not a CEO or something like this of the company. The cost usually is more the hospital and the equipment and things like this. But I can give you an example. Like, first of all, in terms of cost itself, there have been studies that demonstrated that Barricaid is way more cost-effective than fusion. Not only fusion but from doing nothing. Because if you just take patients who had surgery, even just for disc and then you take the patients who will need a second surgery from it, and how many will require a fusion. If you just take this entire population and you compare it to people who had Barricaid from the first index surgery, you still although in the beginning, you’re paying more but overall, you’re actually reducing a lot the cost overall because there is no visits to emergency room for a second problem, less visits, less opioids, less everything, and then no need for a second surgery, which is the cost. And if that second surgery entails fusion, then that’s the whole cause of fusion. So really, Barricaid is not like fusion. All it’s doing is preventing as much as possible the need for fusion from a recurring disc because once the disc recurs, a second time, 50% get a fusion. If it reoccurs a third time, which can happen, almost everyone gets a fusion, almost. So a good cost analysis in that sense, a cost effective.

So, you get what you paid for and pay for it once and pay for it again, right?

Taha: Yeah. And actually, insurance companies seem to be understanding this now. Barricaid hasn’t been there in the market for long. It’s been approved only recently. And she, by the way, our patient was the first done in Ohio.

She told me she found out the day before that the surgery was FDA-approved.

Taha: It’s FDA-approved and all this stuff. But she is the first in Ohio. And so just to give you an idea that it’s a relatively new procedure. In Ohio, I’m the only person who does that. So far and we’ve done about I think we’ve done four and one is coming. So that’s all because it’s a relatively new procedure.

Is that exciting for you?

Taha: It’s exciting for me that I have something to offer the patients other than tell them hey take it very easy, they don’t do anything. It comes back, we’re just going to have to re-operate, and I feel a little bit better by telling them, “Hey, listen, you want to do that trip, you want to go on that trip.” Don’t go bungee jumping. Don’t go diving on me, but enjoy it. Have a good time in your life. So I feel better for the patient. Now, as I said, are we going to have a recurrence? At some point, somebody is going to recur. But it’s a good thing to know that you have a certain technique that allows a good reduction of that chance of to happen. And so in terms of going back to your question about comparing this to fusion and stuff, fusion is a big surgery, regardless of whether you do it minima invasive or not. And I tell my patients, “Listen, we’ll do the fusion minimal invasive, but you’ll go home and you’ll feel that I gave you a good beating.” And that good beating is going to stay there for a while and the first week or two you’re out of commission, and then you’re going to wear a brace, and you’re going to walk slowly, and you may or may not be able to drive a car in two or three weeks. As far as work, forget work. It’s going to not happen probably before 3-6 months at least, that is if it happens. While with Barricaid, it has been implanted on professional athletes so far has been implanted on active military in the country. It has been implanted on firefighters. These are the kind of people you’re implanting Barricaid in which just tells you that they can return earlier to work and activity. And so there’s not even a comparison between them.

Are we leaving anything that you want to add?

Taha: Yes. I would like actually to use this opportunity, if possible to educate the patients as well as insurance companies about Barricaid because it is approved by the FDA. But when you send it to the insurance company, you have to go through a lot of hassle to have it approved. It will. Actually, about 85% of the claims are being approved because once we sit down and we talk to the reviewer and do a peer-to-peer, and we explain to them, listen. Ultimately, this is going to actually save you money, not cost you more money. And this is for the patient, etc. It seems that there are understanding, but we need to get that word out. That’s the most important thing because it’s a good device. It’s a good technique. It helps the patient. And the last thing we want to see happen is insurers saying, “I’m not going to pay for it, and yeah, they need a fusion, let them have a fusion.” It’s just not right.

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

If you would like more information, please contact:

Jake Tanner

jtanner@barricaid.com

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