Can You Prevent a Herniated Disc from Coming Back? | Barricaid Explained

Can a herniated disc come back after surgery? Is there anything that can reduce the risk of reherniation?

In this episode of Bed Back and Beyond, I sit down with Greg Lambrecht, inventor of the Barricaid® Annular Closure Device, to discuss one of the biggest fears patients have after a microdiscectomy: reherniating a disc.

Greg shares the personal story that inspired the development of the Barricaid, explains how the device works, discusses who may be a candidate, and reviews the clinical research that led to its FDA approval. We also have an honest conversation about patient selection, situations where the device may not be appropriate, and why reducing the fear of reherniation can be just as important as reducing the risk itself.

As always, my goal is to provide balanced, evidence-based education to help you better understand your treatment options. This interview is intended to educate patients and encourage informed conversations with your own spine surgeon. Every treatment has potential benefits, risks, and limitations, and no single treatment is right for every patient.

In this interview, we discuss:
• Why some patients are at higher risk of reherniation after a microdiscectomy
• What the Barricaid Annular Closure Device is and how it works
• Who may be a candidate for the device
• Who may not be a candidate
• The clinical research behind the Barricaid
• FDA approval and what it means
• Reasons why some patients still require additional surgery
• Questions patients should ask their spine surgeon
• Hope for patients recovering from a herniated disc

🎙️ About My Guest

Greg Lambrecht is the inventor of the Barricaid Annular Closure Device and has spent decades developing technologies aimed at reducing recurrent lumbar disc herniation after microdiscectomy surgery.

📚 Coming Soon

This interview is the first in a new series exploring treatment options for herniated discs. Future episodes will include:
• An independent review of the published clinical evidence on the Barricaid, including benefits, risks, adverse events, and remaining research questions.
• An interview with neurosurgeon Dr. Betsy Grunch, discussing how surgeons determine which patients may benefit from the Barricaid and how they counsel patients considering this technology.

💙 About Bed, Back and Beyond

My mission is simple: to be a hope and a help for people recovering from herniated discs, sciatica, and spine surgery. Through patient stories, conversations with spine experts, and evidence-based discussions, I hope you'll feel more informed, less afraid, and encouraged that recovery is possible.

Transcript

Why This Treatment Options Series

SPEAKER_01 0:00

Before we begin today's episode, I'd like to talk to you about something that's important to me. I have decided to start a series on herniated disc treatment options. My goal is not to recommend one treatment over the other. I'm not sponsored or anything like that. But my hope is to be a help to you having informed discussions with your healthcare team. With any treatment option for a herniated disc, there's always a potential of risk or adverse events. Treatment options are not one size fits all. What I'd like to do is bring you an episode on clinical data, and then maybe an episode with a doctor's perspective. And of course, as always, an episode with a patient's experience. I would love for Bed Back and Beyond to be a library of resources for patients who are in the midst of this awful injury, trying to make the right choice for their treatment.

SPEAKER_00 0:56

Welcome to Bed Back and Beyond, sharing positive stories of recovery from serious back or neck injury. Your host is CK, a fellow champion who draws on her own experience with perniated disc surgery. Join her as she talks with others who have overcome the physical and emotional trauma of a painful injury. And discover for yourself how you can find hope and encouragement in recovery.

Meet The Barricade Inventor

SPEAKER_01 1:25

Welcome to this episode of Bed Back and Beyond. If you're anything like me, after you've herniated your disc, you spent tons of time on the internet researching your treatment options and what's a microdisectomy and all that. You may have come across the term barricade implant. The barricade implant is something surgeons use to place inside your disc to lower your risk of re-herniation. The inventor of that device is Greg Lambrecht, and I get to interview him for today's episode. Greg has a bachelor's degree in nuclear engineering and a master's in mechanical engineering, both from MIT. He's got the inventor's brain, and he already has several medical devices patented under his name. But his inspiration for the barricade device actually comes from personal experience. He unfortunately had to watch his mother go through multiple failed surgeries of re-herniations leading to fusion and leading to an uncomfortable life after those fusions. I'm excited to have him on today so that you can learn about him and his drive to create a device that lowers the risk of re-herniation after surgery. Greg, thank you so much for being willing to join me on this episode of Bed Back and Beyond. Just so you know, my listeners are made up of people who have herniated a disc and are thinking about recovery or about to get surgery. So I would love to do this podcast from their perspective. But before we jump into the barricade and your company, why don't you tell us a little bit about yourself?

SPEAKER_04 3:06

Yeah, I'm uh I'm Greg Lambrecht. I live in the Northeast. I'm in Boston, uh, where I've lived for the last 25, 27 years. Um I'm an engineer and a physicist. Uh I've been working in medical device and medical device invention innovation since I was 23. I'm 57 now, so that is that ages me. Uh I've worked all over the body, uh, inventions for cardiac surgery and cardiology, urology, obstetric synecology, orthopedics, trauma, hypne. Um, I've really worked all over the body, and uh my goal has always been to identify needs that aren't being met in the world of medicine from a patient perspective, and then trying to invent solutions that perfectly meet that need, as close to perfect as you can get. You never can get perfect in medicine, but you can you can sure try. And so I it's been a very rewarding life. I've been in large companies and small companies um in the first part of my career, and then I started founding my own companies back in 2000. So for the last 20, 26 years, I've been working uh on problems that I get to select and companies I get to start and teams I get to work with.

SPEAKER_01 4:26

How does it feel knowing that you've come up with inventions that are improving healthcare or patient experience?

SPEAKER_04 4:34

It's you know, uh as a as a recommended career, it's fantastic. Um I I uh I would highly encourage any engineer or anybody that is interested in medicine of considering this pathway. Um, I think about uh the other choice I had was being a doctor. And uh as a physician or a surgeon, I get to affect one person's life at a time. Uh as an inventor, I get to create an object or a solution that can potentially affect hundreds of thousands of people uh every year. Uh and so I I don't have that direct contact with patients as as a physician does, not as often in any way. But I do get the reward of knowing that the devices that I've worked on and been a part of, and the surgeries I've been a part of, have, and the teams I've worked with, that our output is making a positive influence every day uh in in multiple countries and lots of populations. And it it's a it's uh an incredibly rewarding feeling.

A Family Story That Sparked It

SPEAKER_01 5:40

How did you end up in the spine space?

SPEAKER_04 5:43

Oh, uh, you know, when I started founding my own companies, I wanted to work on problems my family had. Um I I had had spinal injuries growing up surfing in Southern California. I um uh broke a bone in my back, uh one of the pars in my lower back, uh, and I shattered a vertebrae in my neck. Uh surfing is dangerous, so beware. Um but I started I started working in the spine because of my of my mother. She um she was in her 50s when she had her first discarniation, early 50s. Uh I was she was a single parent um and single income. And so when you're affected by a discarniation, as you know, it's it's uh you try hard to get better without surgery, but that wasn't working. And ultimately she had surgery. Um, and then unfortunately, uh about six months to a year later, she had a recurrent discarniation that was even worse than the first one. And so she had a second surgery. Uh, I was working in orthopedics at the time in hips and knees and arthritis. And uh then she had a disc herniation at another level in her lower back, um, her L5S1, her lowest level, had foot drop, uh, and so had to have emergent surgery, and then had a recurrent disc at that level. Um I that's when I started the company. Um, I was like, something is fun is clearly wrong here. Um, how can she have a surgery that treats the problem and then the results aren't durable? So she felt great after her surgery. She felt fully recovered in both uh circumstances. But then both discs failed again. The same way, same side, same pain, maybe worse. Um so I started the company for that reason. She went on, unfortunately, to be fused at both levels, and she's now uh had uh a failure above that fusion, uh, which she refuses to get surgically treated because look at all this result of surgery she's had. And she's had a prolonged opiate dependency that she's now now broken free of. But you know, I think about the trajectory of her life in her 50s, she was doing great, right? And then this series of events really changed the trajectory of her life and altered what she could do, what she wanted to do. She was a mountain climber and a hiker living out in California and you know, lost all of that ability. And one of the things I've come to recognize in in medicine is that I find greater value in working on people who are younger because you save more life. And so if there's a way, we founded the company, and I was like, if there is a way that we can make this first surgery the last, um, how do we make the results of that surgery more durable?

SPEAKER_01 8:51

I often think back to my own experience when I herniated at my disc back in 2019. And sometimes the emotional guilt I think about is what my husband went through as someone watching me and being helpless and knowing that there is nothing he can do except for be the emotional support to help me through. And so I can't imagine an inventor have watching their mother go through such such a process and then fix this.

SPEAKER_04 9:24

Yeah, she she wasn't a candidate for my device or our device um by the time she, you know, we we were ready. Because it's it's a tough problem to solve. It's one that surgeons have been trying to solve since the surgery was invented back in the 1930s. Um how do we stop this from happening again? How do we prevent recurrence?

What Microdiscectomy Actually Does

SPEAKER_01 9:45

Um do you do you mind um talking a little bit about what happens during a microdisectomy to the disc?

SPEAKER_04 9:52

I mean, uh the great thing about a microdyspectomy is the incision is small, right? Yeah, but you're lying on your front, um, generally under general anesthesia, although there is some movement toward just using a spinal block, um they where they just shut down your nerves. Uh they make an incision about one inch um just directly above your disc that uh they have to treat. So the disc is ruptured, the nucleus, uh the stuff on the inside of the disc has come out toward the back, so they get access to it from the back. Um, make about a one-inch incision, uh, work their way down to the bones that are shielding the back of the spinal canal uh where the nerves are. They remove uh a ligament and uh some of the bone that's that's in between them and your disc. Uh they retract your nerve carefully in the and the door next to it, uh which is the the lower end of your spinal cord. They pull that toward the center, center line. Um, and then they come in and grab that piece of disc that's come out and it's compressing the nerve and take it off of your nerve. Um, it's about a 45 minute to an hour-long procedure uh the first time around. Um the the complexities of it when I talk to surgeons is now you've taken this fragment out, there's still a hole in the disc that that fragment came through. Most of the time it's you can see it. Um how much more disks do you take out from the inside of the disk? You've got to take the stuff out that's in the spinal canal where it shouldn't be. But how much do you go into the disc and take out more? And the theory, the conflict is I I want to leave as much of the disc behind as possible so that it keeps doing what it's supposed to do, uh separating your vertebra and allowing you to bend and flex, um, protecting the nerves out to the sides. Um but there's this risk that the disc will come through that hole again. And I don't want that to happen. So, you know, people will try to go into the disc with a little biter and pull out a little bit more and feel around for something that's loose to make sure that nothing more is going to come out. Maybe they'll flush it with saline to try to get anything loose to come out. They're frightened of recurrence or reherniation too. Um, and then at the end of the procedure, they they uh close the the muscle above and and the skin above, and that's it. So you're you can have a couple of band-aids on your back uh and this one-inch incision. They're so it's a it's a quick procedure. It's a it's a it's a surgery they start doing, spine surgeons will do when they're young and right out of practice, like right when they start. Uh, and I've noticed they come back to it when they're older because they uh they don't want to do the complicated stuff anymore. And um dyskectomy makes patients feel so much better.

Why Surgeons Cannot Close The Hole

SPEAKER_01 12:55

Right. Now, a question I see often, especially on the forums, is why can't they just close the hole? Can you can you answer that for us?

SPEAKER_04 13:04

I thought it was gonna be easy too. I was uh standing in a surgery and I asked that question of a of a surgeon. You know, he was treating a young woman and he pulled the fragment of disc that had gone into the space into the nerve area. He had just pulled it out and he said, There, I've cured her. And he went back into the disc and he was ripping out the rest of her disc. And I was like, if the first piece cured her, why are you what are you doing? And he said, Well, the she has a big hole in her disc, and there's no real healing of that hole. And I'll go into that in a second. And so the risk that more discs was come out is is gonna come out is really high, and I want to stop that from happening. I was like, Isn't it bad to take out all of her discs? He's like, Oh, yeah, her disc will collapse and she'll have bone pain and facet degeneration and stenosis of her spine, and then I'll just fuse her. And I remember saying, What if I could just close the hole? And he goes, Oh, that'd be great, but it's impossible. And so, what makes it not impossible, but very hard? The pressures on the inside of the disc are enormous. Uh, highest pressure ever measured in the human body was measured in the lowest disc in the lumbar spine, lower back. And it's uh as much as 10 times your tire pressure. 350 pounds per square inch. Um, if you bend forward and lift an object up without bending your knees, you are creating an enormous lever arm that's squeezing on your disc. And so uh over preventing that holding back that pressure has been the biggest challenge. The second part of it is that the disc is under so much load and pressure that there's no way for the blood supply to get to it. So the disc doesn't have any veins or arteries going into it or out of it. It lives by sucking water in from the bones around it at night when you lie down. And as a result, it has no blood supply to heal. And so the the hole doesn't close in any meaningful way.

SPEAKER_02 15:08

Okay.

SPEAKER_04 15:09

Uh you can get some loose scar tissue, but the the annulus, the outer structure of the disc, the tire of the disc, imagine its its job. It has to hold back 350 pounds per square inch and allow you to move around. Um, and so it's one of the most beautiful structures I've ever seen in the body. It's multiple layers of these tough fibers that are rooted into the bones above and below, like a hose. Like if you've seen those beautiful firemen's hoses, it's those nylon layers back and forth to allow you to flex without it leaking. And um, and scar tissue is just generally amorphous, no real structure. It doesn't bond to the bone. So once you have a hole, it's there forever. And so the that risk of recurrent discreation is continuous. So and no blood supply for healing. That makes it really high, hard. High pressure, uh, no direct healing, uh, hard to sew. Uh it's it's uh it's like sewing cheesecloth. Um, you pull and it'll separate where you're pulling. People tried sutures, they tried glues. Um motion is too much for glue. Sutures, there's no direct healing and they pull out. Um, so it was a it was a really hard problem to solve.

Who Faces Higher Reherniation Risk

SPEAKER_01 16:29

And is there a person who is at greater risk for reherniation?

SPEAKER_04 16:34

Yes. Uh there, and there are a couple of things that drive up your risk. Um, one, you're completely out of control of. Uh, the size of the hole in the disc at the end of surgery has been very strongly correlated with risk. If you have a very small hole, like a pinhole uh in your disc that your nucleus, your discs, uh, the inside of the disc happen to make it through, if they just take that fragment out and can't find a hole, your relative risk of recurrence is very low. It's like 2%, which is great. A 98% successful surgery. That's the best surgery in spine. Um the problem is that sometimes the hole's quite big. And it doesn't need to be that big to create a lot of risk with those pressures. So there's good data that shows if it's six millimeters, so what is that? An inches, it's about a quarter of an inch. Um, any hole that's about a quarter of an inch wide or wider puts you at about a one in four chance of re-herniation. So that's the biggest factor. There are other factors. Um uh being young and female. Uh I think your flexibility is higher. Uh flexibility is maybe not a good thing for the for the disk and recurrence risk, sadly. Um, so young and young and female, um, old and male, uh, I think that's just stupidity. You know, we do dumb things that we think we did when we were young and think we can still do them or older.

unknown 18:01

Right.

SPEAKER_04 18:02

That ruptures discs, um, recurrences. Uh so those are those have been correlated as well, but the biggest one is size of the hole at the end of surgery.

SPEAKER_01 18:11

I I mentioned that my surgery was in 2019. I didn't, I don't even know what my whole measurement was. I'm not sure that doctors actually share that with their patients. Probably for the mental concern.

SPEAKER_04 18:24

Before before Barricade, which is the product we make to it's designed to close the hole, um, there was no reason to measure, really, because there was nothing you could do.

SPEAKER_02 18:36

Right.

SPEAKER_04 18:36

Um some surgeons, when they see a really big hole, will remove a lot of disc to try to prevent recurrence, uh, knowing that they are causing disc collapse and eventual back pain. They're trading off the protection against recurrent discrimination from the generation of new back pain. Uh, and they're making that choice, hopefully consciously. Um, and if I were a if I were a patient, I I would ask, you know, if you find a big hole, what do you do? What's your plan?

SPEAKER_01 19:08

Right.

How The Barricade Implant Works

SPEAKER_01 19:09

So that's where barricade comes in.

SPEAKER_04 19:12

Yeah. I uh my mother clearly had two discs with big holes in them. And um, so how do you close it? Uh one thing that we realized is we had to act like the annulus, that tire-like structure, and we had to be anchored to bone. To be able to hold back that kind of force, we had to anchor to bone. So very important part of our system is a very small um titanium bone anchor that is attached to one of the neighboring vertebrae. So you've got two vertebrae around every disc, one above and one below. And so the surgeon can then plant the anchor into either one. And that anchor is pre-attached to a flexible flexible polymer component. It acts like a catcher's mit uh that sits in front of the hole inside the disc, waiting for nucleus to try to get out. And it will, if the nucleus tries to get out, it'll catch it. So that that catcher's mit, that flexible polymer component is is securely attached to that bone anchor. So the nucleus hits the the the flexible polymer, that flexible polymer, which doesn't limit your ability to bend, uh flex, extend, do anything you won't normally do. Uh that flexible polymer is hit by the by the nucleus, the nucleus tries to get out, and the anchor holds that barrier in place and prevents it from leaving. So that's the uh that's the idea of the barricade. It's a it's a small thing. Um it's uh most 10 millimeters wide, so just under a half an inch.

SPEAKER_03 20:40

Okay.

SPEAKER_04 20:40

Uh the polymer component. And the the the tiny anchor is is about a quarter inch uh in in width and about a half an inch long. Uh and so they tap it in with a a mallet at the end of the surgery, and it automatically pushes the the flexible component of the barrier into the disc and uh simultaneously drives the anchor into the bone. And there's nothing left in the epidural space, there's nothing left in the nerve area, it's all on the inside of the disc.

SPEAKER_01 21:10

Does the bone involvement mean that the surgeon's incision needs to be larger, or can they still keep it a minimally invasive surgery?

SPEAKER_04 21:18

Minimally invasive, absolutely. So same incision that they normally do. Um it can take a little bit more of a removal of the bone that that is right behind the disc that's between you and as a surgeon, between you and the and the disk space. Um, but uh it doesn't result in anything negative. There's no instability, or they don't have to take all of the bone out, they don't have to do a laminectomy or anything. Uh they already make a little bony window, they just need to make that slightly larger.

SPEAKER_01 21:44

Now I know you've gotten FDA approval.

FDA Approval And The Clinical Trials

SPEAKER_01 21:47

What does that mean to a patient? Can you just uh summarize that process and why should a patient care that it's gotten FDA approval?

SPEAKER_04 21:54

Yeah. Uh there are two different pathways through the FDA for a medical device. One is uh Pathway of substantial equivalence, and one is a wholly new device, and the regulatory burden is different. Something that is substantially equivalent or substantially similar to an existing device does not necessarily need any clinical data at all. So, say for example, you've got a hip replacement, and this new hip replacement is a different size. That can go through this easier pathway that doesn't necessarily require clinical trials.

SPEAKER_03 22:27

Okay.

SPEAKER_04 22:27

And a lot of devices, the vast majority, if there are a thousand medical devices approved, 999 are approved that way. We did not go that path. We're a brand new device for a brand new indication, which meant that we had to have randomized prospective clinical trials demonstrating that the group of patients that were implanted with barricade did better than the patients who weren't. So the patients who weren't implanted got the standard surgery, and the patients who were implanted got the standard surgery plus barricade. And so we ran a uh three-year follow-up randomized prospective clinical trial for the FDA. All patients, 554 patients randomized in the operating room between getting barricade or just getting the standard surgery, and then followed for at least three years. We've now just completed our 10-year follow-up, which is great. And when the FDA approves a new device for a new indication, they make you show them everything, right? They're involved and they audit the trial sites. They are the rigor of the FDA is impressive and worthwhile, I think. Because what it gives is the confidence in the results. And so what the trial showed, and what all the trials have shown with barricade is an 81% reduction in reoperation uh related to recurrent disk. So it's a dramatic drop. That drop was statistically superior. The group with barricade was better than the group without from three months through five years. And now we're going to show through 10 years once that data is published. So uh it by by blocking the hole reduces the risk of recurrence, was shown in the trial. By reducing the risk of recurrence, you knock out the primary reason for reoperation. And so uh and we did that without increasing complications, we actually decreased complications, without change without making your pain worse in any way. So all the other things were equal or better for barricade, uh, while we dropped the rate of reherniation and reoperation.

SPEAKER_01 24:39

And I think you you started in 2020. Was that when the FDA approval was was given? Was 2020? Yes.

SPEAKER_04 24:46

Yeah, 2020. The trial started in 2010. Yeah, it was a long process to get through the FDA.

SPEAKER_01 24:51

My surgery was 2019.

SPEAKER_04 24:53

Yeah, I'm so sorry. You know, this is one of the things that drives my team every day is we think about every patient on the table and making sure they have access to the best technology that's out there for prevention of uh for failure. I mean, it's uh you people, there's two types of pain that come from failure. One is the actual failure, where you have unfortunately a recurrent discarniation and need of reoperation or or or physical therapy or all the things that you go through to try to avoid reoperation. The other thing is the fear of reoperation and how that changes your life.

SPEAKER_01 25:31

Yeah, that's why I started this podcast.

SPEAKER_04 25:35

I agree. Right. It's it is what a great reason to start. It's um my mother's view after her the the first herniation of her second disc. Boy, did she change her life trying to prevent that next recurrence. Uh, and not for the better, right? It's uh you take out exercise, you decrease your contribution in your family. You're no longer the one who's gonna pick up the groceries, you don't pick up your kids, you know. You don't, there are all these things you fear. Right. And you know, the hope is we can reduce or eliminate that fear as well. Right.

When Barricade Fails And Why

SPEAKER_01 26:13

Now I know there's no medical procedure that is 100% effective. Um, I love the the phrase medical practice is practice.

SPEAKER_03 26:24

Yeah.

SPEAKER_01 26:24

So I'm sure you've had some failures with the the barricade implant. Do you see um a correlation to the the disc was just bad and maybe it's re-herniated on the other side? Or is is there a trend that you're seeing?

unknown 26:41

Yeah.

SPEAKER_01 26:42

It doesn't always work.

SPEAKER_04 26:44

The it doesn't always work. 81% reduction means 19% didn't, right? Right. Uh of the not of the eight, not 19% didn't succeed. It's that we reduce the rate. So if you have a 25% reduct uh rate of recurrence without barricade, we drop it to, you know, around 5%. So that means 5% uh are being um or have a reoperation. So what are the causes for reoperation in the barricade group? It's normally that the nucleus gets around the barrier. And um, that can happen for one of two reasons. Uh either the surgeon undersized, so we have a measurement step and we have two different implants. Um, and we did have a streak of undersizing when we were originally doing trials, uh, even in the trials, and we saw that that correlated with recurrence risk. So we have an eight millimeter wide, and if they put an eight millimeter wide into a nine millimeter wide hole or a 10 millimeter wide hole, it's not perfect. And so we we we strongly recommended surgeons don't do that, um, that you implant the appropriate size, equal to or wider than the hole you measure. Um that the annulus is degenerated further, that there was damage that continued. You can either have a herniation on the other side, which is extremely rare, um, 1% uh of the time, uh, or the the hole just got bigger and you you get nucleus around. Um, and what's important to me as an inventor and us as a company is that you don't burn any bridges, that if somebody gets your implant, the same surgeries that they use to treat the patient without your implant are available to them. Uh there's a wonderful article published by one of the surgeons in a randomized clinical trial where he analyzed the reoperations in in both the barricade group and the control group. And he said they were for the same reason, uh, they were the same surgeries applied, they had the same intra and perioperative or near surgery complications, and they had the same long-term outcomes. There were just a whole lot fewer in the barricade group. So we did introduce a new problem, which is great. And uh and the surgeries that they use now, they can still use.

SPEAKER_01 28:53

Now, I imagine you're still uh slowly gathering

Finding Surgeons And Insurance Coverage

SPEAKER_01 28:56

doctors that are willing to use the device. Um, if a patient has seen this and thinks, I want a barricade. Do you have any kind of resource where they can find doctors that use your device?

SPEAKER_04 29:09

Yes, yeah. Go to our website at barricade.com and there's a surgeon finder for sure. Um and we are in all states. I don't know that we're in Alaska, but we're in the vast majority of states uh by this point. And uh we have surgeons in each. Um, and so uh definitely feel free to take a look at the website. You can reach out to us uh anytime through that through that website. There's a contact form. Um and then ask your surgeon. More and more surgeons are doing uh using barricade all over the country. Uh the the the big the bigger question is insurance. Um the insurance companies are, I think we're we're at about 40% coverage now across the country, um, which is pretty quick for a new technology. Um and we're really rapidly pushing on that, and we're beginning to see so societies are supporting barricade, the spine societies are supporting barricade. Um the their efforts are helping to push the insurers over the over the edge of you know, finally paying for something that actually reduces their cost and makes their patient feel better because we do both. Um, and then surgeon coalitions have been arguing effectively with uh with the insurers um to to achieve coverage. So we have full coverage through Cigna. Uh they were the first national cover to to pay for barricade. And then we have um coverage all over the country um in pockets. Uh so it's it's worth talking to your facility about about coverage. We also have a program where um we will work with the center to fight every appeal um uh to make sure that that as many people, it's a program we call patient first, to make sure that as many people as possible have access to the technology because we know it works.

SPEAKER_01 31:01

So if a patient's insurance denies coverage, they can then call.

SPEAKER_04 31:06

Depending on their facility. So we work with a facility. The facility has to accept our program. Um but we have a lot of facilities who do because they want to fight for uh the barricade.

SPEAKER_01 31:17

That's great. So who is the perfect candidate for a barricade?

Ideal Candidates And Who Is Not

SPEAKER_04 31:23

Perfect candidate. Uh 95% of the disc herniations are in the lower two discs of your back, and that happens to be what we're approved for. So uh we're not approved for the thoracic spine or the neck, um, and we're not approved for the upper upper levels. Um, the vast majority, good news is the vast majority of discs are approved and covered. Um, if you have um you need to have some disc height remaining. So if your disc is completely collapsed already, unfortunately, we're not available. That's what took my mother off the list.

SPEAKER_02 31:54

Right.

SPEAKER_04 31:54

Um, that her disc had already collapsed uh by the time she got to us. Tiger Woods, same thing. Um, right. Too many surgeries. Uh so you know it's it's um L45 L5S1, uh discarniation age doesn't really matter. Um so it's as applicable to a young person as it is to an old person. We've implanted 18-year-old gymnasts and 75-year-old farmers. Uh so that don't worry about that. Uh male-female doesn't matter. Osteoporosis does. Okay. So if uh what's interesting is most people with discarniations don't have bone density problems. Um that's why you're disruptured and not your bone. Uh so uh tends to not take out many patients. So if you've got a discarniation in your lower back and um the images show that you've got uh remaining reasonable remaining disc height, we say five millimeters or more. Uh I would talk to your physician about barricade.

SPEAKER_01 32:51

Is there any patient story that has stood out to you?

SPEAKER_04 32:55

Oh, so many. Um young Air Force candidate, um, lifetime dream to fly. He had a disc herniation when he was in candidate school and was worried it was gonna take him out of being a pilot. And so implanted with um implanted with barricade, wonderful surgeon, um, great result. Uh didn't realize he was training for the Leadville 100 when uh and so uh ran the Leadville 100 with uh with his barricade um and just recently um certified as pilot. Uh so that's a great story. Being able to take somebody so young and protect the dream that they had uh is always a really a really really positive thing. Is there any you know parents? Somebody who's got a kid, right? And uh we fought with this one insurer in uh in North Carolina for years, uh it felt like years, sorry, probably, probably about six months, uh trying to get her access to it. And and um they kept denying and kept denying, and she ultimately went forward and had a dyspectomy and then had a recurrence and then had a fusion, and uh, I think about her every day.

SPEAKER_01 34:26

Yeah, I see moms a lot on the forum, and they just they're suffering with depression and guilt because they can't lift up their children,

Fear After Surgery And Activity Limits

SPEAKER_01 34:35

and then they go through the six weeks of no bending, lifting, or twisting, and then they're scared to pick up their children.

SPEAKER_03 34:40

Yeah.

SPEAKER_01 34:41

Have you seen the implant remove a lot of that emotional stress for people?

SPEAKER_04 34:47

Um increasingly so. And you know, it comes down to what the doctor tells the patient. Um, doctors will say no bending, lifting, twisting, six weeks, nothing over five kilograms or 10 pounds. Um, because they're frightened. The surgeon is frightened, honestly, that you're gonna have an early recurrence. And a lot of recurrences happen within the first three months. That's the that's the spike. Um and so they they really want you to avoid that outcome. Um we now have surgeons who use barricade. We had we had uh center in the clinical trial, a randomized clinical trial. We didn't give activity restriction instructions in the trial, we just didn't think of it uh for either group. And so they just told the patient whatever they normally told the patient. And this one guy uh said, I hope you're not gonna get angry with me, but I told the barricade patients they can go right back to full activity. And uh we looked at his results, and his results were great. Uh and so we've been seeing increasingly surgeons saying, I'm not waiting for scar tissue. I'm not waiting for anything but your incision to heal. Go right back to it. Um and we're seeing increasingly that that happened. And so uh we're actually running a randomized trial right now where we're everyone's getting access to barricade and we're randomizing these barricade implanted discarniation patients into two groups after surgery. Six weeks conservative care, no bending, lifting, twisting, or go right back at it. And we're gonna see. We love clinical data. I'm a nerd. I'm sure I apologize. So we're gonna see, can we take that away? Can we eliminate that restriction and let you go right back to it? Is it just as safe? Because now you've got barricade, it's blocking the hole. The cat rid is there, right? Um and and so I'm I'm excited to see the results of that trial.

SPEAKER_01 36:43

Yeah, yeah. Well, you know, restricting the movement for six weeks has such a negative effect on the muscles. And then when you start to move again, it creates a whole new set of pain. So, you know, I understand the need for the no BLTs, but at the same time, uh, it creates such such a uh recovery experience that also adds to that.

SPEAKER_04 37:06

And puts you at risk. Yeah, I think I think one of the things that causes re-arniation within the first three months is that you've taken six weeks off and and now you start to go back to it, and now you've lost all of your muscle, right? And you don't have this the stabilizing effect of those muscles on your spine, which is so important for I mean, my advice to all patients is core strength, core strength, core strength. Yes, do a lot of get the plank, is your friend, right?

SPEAKER_03 37:34

Plank is your friend.

SPEAKER_04 37:36

Plank is your friend. Core strength matters, but you know, people I saw this one young woman at a uh at an event that was unrelated to barricade, um, standing against a wall. And everyone was grabbing little plates of food and a glass of wine at this nice event, and she hadn't. And I I went over to her, I was one of the hosts of the event, and I I asked, you know, can I get you something? And she goes, Yeah, you know, I I had a dysquectomy four weeks ago, and I am terrified of bending, lifting, or twisting. Like I'm terrified. And uh and I it was the first time that I really realized, wow, this has a huge effect on people. Yeah, yeah.

SPEAKER_01 38:17

I lived that. I, you know, I had the surgery. They all they said was no bending, lifting, or twisting. So I I took that and I lived it to the T as if I was in a brace. So I wouldn't, I wouldn't move at all. And then physical therapy started, and the therapist said, Christine, they didn't they didn't mean don't move at all. That's what they said, no BLTs. And so recovery. And then even months after, someone came up to me and said, Christine, I noticed

Long-Term Recurrence Risk And Core Strength

SPEAKER_01 38:44

that you're still not moving your back. And I was like, What? Yeah, like when I would turn for something, I would just turn my whole body instead of using those muscles. Um were you in 2019? I'm I'm I'm I've dropped it.

SPEAKER_04 38:59

You know, we it it's what it's what drives the company every day. It's what drives everybody at the company every day.

SPEAKER_03 39:05

Yeah.

SPEAKER_04 39:06

Is how do we get how do we how do we give access to this for the people who need it? Right. If you if you have a small hole in your disc, this is one of the biggest things about barricade. You don't know if you're gonna need it. Um, you get it approved in advance uh by the insurer, and then you have surgery. And I have to tell you, if you wind up not getting it, and the reason is because your hole was too small, thank your lucky stars.

SPEAKER_01 39:32

Yeah, and that's good to know.

SPEAKER_04 39:34

That's it's great. Hey, you didn't need it. You got the best surgery that you need um for your problem. And then if you got barricade, hey, I'm glad we had barricade, right? Right. You had a big hole, we closed it. You know, now you're you have the same risk as the small hole person. Right. Um, and so that's the you don't know if you're gonna get it, but it it I would love for it to help eliminate guarded motion because that's a change in your life um that goes beyond the immediate pain from the injury itself.

SPEAKER_01 40:12

Uh that that's just so great to know. I was gonna ask you what do you wish patients knew going into surgery? And I think just knowing that.

SPEAKER_04 40:20

Yeah, be careful of muscle, muscle weakness and loss after surgery, given the activity restrictions. I mean, find it's maybe even have a conversation with somebody in PT during this six-week period before you start the PT exercises, and say, what can I do to maintain or build the strength that I will need to help stabilize my spine going forward? That that prepare yourself. And is there anything I can do now? Is there something I can do without bending, lifting, or twisting, right? That I can do that is going to give me the best chance of recovering. And this is true whether you have barricade or not. Like just whatever it is, uh, start early. Um, be active in your pre-operative, post immediate postoperative, and recovery.

SPEAKER_01 41:12

Yes, I can say, unfortunately, seven years after my surgery that I have now reherniated. And uh that's because I didn't keep up with my core exercises.

SPEAKER_04 41:22

Oh, I I am very sorry. Um I am very sorry. I I want recurrence to go away. It's yeah, it's true. You your greatest risk is within the first three months, the next greatest risk is in the is before a year, and then unfortunately your risk is constant and at about a 1% a year for the next 10 years.

SPEAKER_02 41:46

Okay.

SPEAKER_04 41:47

And so five to ten years. And so you're, you know, it it can still happen late. And uh, you know, I my this is why we're publishing our tenure data. Uh, is that we wanted to eliminate these early ones, reduce the early ones, and then minimize the later ones, certainly not be worse. And so what we're seeing is that the gap opens up at three months, it widens at a year, and then it stays constant through five years and ten years, that gap and risk of reharniation or reoperation. The people, the number of people that were reoperated in the control group is always, you know, that big gap between them and the people that were reoperated in the in the implant group. But it's not zero, right? And and so, you know, if we can get it down to that one percent, right? If you can protect that first year and then that one percent, I don't know if we're gonna help with that, uh, because those tend to happen for a variety of different reasons.

SPEAKER_01 42:45

So are you still working on the

Improving The Device And Convincing Surgeons

SPEAKER_01 42:48

barricade and making improvements, or have you moved on to the next invention?

SPEAKER_04 42:54

I well, yeah. I I can't help but invent. So you know, there are three categories of working really hard at intrinsic. Um, number one, insurance companies. Uh they don't necessarily do what's best for them or for you. Uh barricade is best for both. Convincing them that that is true is hard, hard work because they're being distracted by everything else. Um, and they have a profit motive and so don't want to make a mistake approving something that shouldn't be used. Um we are making headway, but it is a it is a coordinated effort between patients, surgeons, uh, and our team to harass the private insurers until they change. Uh Dr. Betsy Grunch, uh really wonderful spine surgeon, uh, who's got a great Instagram feed. She she um she was part, she was a big part, she and a bunch of other surgeons were a big part of Cygna becoming positive coverage. She recorded patient. Stories with and without barricade and sent them to the insurance company and said, here's what you're doing.

SPEAKER_02 44:05

Right.

SPEAKER_04 44:05

Right. And so that's a big chunk of what we want to do. The second is how do we make it so easy for the surgeon to do, right? So so quick and easy that they would have to think of reasons not to put it in. Right. And so we've learned a lot in the in the oh, we've our first implant was in the first clinical trial in 2008. So what is that? Almost 20 years that we've been in implanting in patients. And the the instruments have improved dramatically to make it easier and easier and easier to implant. Implant side, we we uh I want to I would love to completely and utterly eliminate uh reherniation risk. Uh we're great, not perfect, right? We're at 81% reduction. Right. Uh so you know, around a five percent risk at at uh one of two years, right? That region. Um I would love to get that to zero. Um so how do you go in small and get big? How do you go in as a tiny thing and block a big hole? Right. Um there's still some people whose holes are bigger than we can close. So, you know, how do I how do we as a team make that happen? Um, we have a bunch of ideas, but the the the thing in medicine is you always want to make sure that you do both. You improve efficacy and improve safety. And so how do we make something that doesn't break that gets big? Our device doesn't break, right? Exceedingly low mechanical failure rate, like goofy, goofy low, like three in 15,000 kind of breakage rates. Very, very low, and normally from a weird poor implantation. Um so you know, I don't worry about failure of the device now. Um so I don't want to introduce a new failure mode. So I I'm I would love to find a way to close more holes, block future holes, um, make that first surgery the last um without introducing a risk. And so uh we're very cautiously carefully, because we have such a rugged system right now, uh, and the spine is a violent place, uh, that that if we can come up with something that we really know, and we've got great ways of testing it. We know more about testing things for the spine than anybody else in this indication. So if we can make something, I would love to do it.

SPEAKER_01 46:37

Yeah. I in my mind I'm envisioning people that make the ships in a bottle have to reach in and unfold or unfold the sails.

SPEAKER_04 46:46

It's you know, it's uh first of all, the great thing is the goal is good, right? And that's a beautiful thing about medical practice is that everyone has this an incentive for this to be successful, right? Patient, doctor, hospital insurer. Um, they don't like paying for complications, healthcare system, FDA, uh, they all want it to work, uh, right? And they all want it to be perfect. And so it's a it's a great thing to be able to work on something when everybody wants it to succeed.

SPEAKER_01 47:17

Yeah, I imagine that some surgeons can be a little bit um difficult to convince. There's that, you know, the tried and true way. How do you go about convincing surgeons that they want to incorporate the barricade into their practice?

SPEAKER_04 47:32

Yeah, it's it's uh it's a little bit like calling their baby ugly. Say saying, you know, you recognize you have a recurrent disc herniation problem. This is something to address that problem. And you know, the resistance that we run into is is um it's three different types. Uh one is I don't have a problem. My patients don't have reherniation. That doesn't, my hand, I'm I'm perfect at this. Um and my my my snarky question that I ask after that is do you operate on um your neighbor surgeons' failures? Oh, yeah, all the time. And like, might that mean that your patients aren't going back to you? Right? So the that's that's a hard one to um to fight because they don't believe they have a problem. And normally with that surgeon, I'll say, the next time you have a recurrent discrimination, please think of us. And when you have it, think of us. It's not every one of your patients, it's these patients with large holes. And if there's a minimum you want to do that you could do in your practice, is measure the size of the hole. We'll give you these measuring sticks and just use them and see how many of your patients that come in have these six millimeter or larger holes. And and that works uh sometimes. Uh the the second resistance is this is impossible. This problem is too hard to solve. People tried sutures, they failed. People tried glues, they failed. There are a lot of spinal medical devices that fail uh mechanically that aren't in this space. You know, you're another one of these things that's gonna put my patient at risk and is selling snake oil, right? That's their fear. Right. Um, the great thing is that we have more clinical data published on barricade than almost any other spinal implant. So you want to trial um

Medicare Vs Private Insurance Reality

SPEAKER_04 49:29

for the effect of nucleus removal on disc height, we've got one. You want a trial on you want to look at uh young female patients with uh large annular defects, you you can look at that patient population. You want to look at pay people over the age of 65, you can look at that population. You want to look at the risk of reoperation, you can look at that study. So I love that resistance because we can overcome it. Um, they recognize they have a problem, they care about their patient, they fear failure, um, introducing a new problem for their patient. They're thinking the right way, and we have the data to address their concerns. That's a great one. The third one is I'm not gonna get paid. So no matter how good you are, no thank you. Right. Right. I'm not, or my hospital's not gonna get paid. Right. Uh, there's a fear of non-payment, especially with something new, that is overwhelming. And uh, and so what we do is our we have a team that has actually collected payments from hospitals and physicians for thousands of surgeries for barricade. And they're able to show them here's what you get paid for doing barricade, and here's what your facility gets paid for doing barricade. Right.

SPEAKER_01 50:48

When do you get out of the considered new? Because you said you're coming up on your uh you'll have 10 years of data.

SPEAKER_04 50:55

10 year published data. This is the the nightmare of American healthcare. Um, there is so we're not considered new by Medicare. Medicare fully covers us. Right. Completely. You're over the age of 65. Uh, you have Medicare, uh, careful of Medicare Advantage. That's my advice to all the patients out there. The only advantages to them, uh, straight up Medicare is great. Uh so Medicare, no problem, you get the barricade. Military, no problem, you get the barricade. Government has approved it left and right. Your TriCare.

SPEAKER_01 51:27

That's shocking.

SPEAKER_04 51:28

Yeah. There they they were involved in the design of our clinical trial.

SPEAKER_03 51:33

Okay.

SPEAKER_04 51:33

Um, they told us to enroll patients over the age of 65, and we said, okay. Uh we argued with the FDA for like months over including people over the age of 65. Um, and we finally refused to give up. And so we implanted a bunch of patients over the age of 65. And Medicare issued a payment code for barricade on the day we were approved, actually, a couple days before we were approved. So I'm impressed uh by Medicare and TriCare. Uh the private insurance, there is no, there are no requirements on them. Uh, there is no published hurdle you have to you have to cross to achieve coverage. None. And and it's probably proprietary. Each insurer keeps that to themselves. Um, which is a flaw in the American healthcare system. It seems irrational that if Medicare has to cover it, that private insurance doesn't have to cover it as well. Uh to me, if there was gonna be a law passed, it would be that. Uh right, then private insurance must cover uh things that are covered by Medicare. Um, you know how long they call it experimental investigational. Um we're falling off of people's lists of experimental investigational. There's three stages non-coverage, I don't want this. There's silent coverage, I don't know. Uh, and then there's positive coverage, Cigna. Yes. Uh Anthem just switched a couple of days ago uh in a bunch of different states, saying card benefit. Um so we're working every angle we can to try to address every concern they've got to get through.

SPEAKER_01 53:19

Are there any final thoughts you would like to say to a patient who is currently watching this and and wondering what their options are or just feeling scared about surgery?

Final Advice For Scared Patients

SPEAKER_04 53:29

Yes. Um avoid surgery unless you absolutely need it. You absolutely need it if it's not going away um after six months or six weeks plus, or getting worse, or you have neurologic compromise that is affecting your motor. If I had a disc herniation where I had foot drop, I would try to get surgery within the next 48 hours. It's like a heart attack for your nerve. And there are good studies that show uh foot drop recovers much better if operated within the first two days. So if I had foot drop, I'd get surgery right away. Otherwise, I'd try to avoid it. I've had a disc herniation. It dropped me to the floor. I'm crawling around on the floor of my basement thinking that I was going to live there for the rest of my life because I wasn't getting up. Um, but I like 90% of people got better without surgery. Um it comes back. I will have little reherniations and they all get better. Um, so if I had gotten any worse over those next six weeks, I would have had surgery uh to recover. And then, you know, be very active in your care. Uh, have good conversations with the physician and the PA about their surgical philosophy. You know, what do they do when they see a big hole? How much disc do they remove? Why do they think that way? You know, trust and understand your surgeon if you need surgery. And maybe even get to know who the PT people are before you get surgery. Right? Because that PT process, the core strengthening and the things that you can do to try to stable your spine, that's another way of being active in your care. And then if I, of course, had a needed surgery, I'd check for somebody that was familiar with barricade. I'd want it to be in the room.

SPEAKER_01 55:27

Greg, thank you so much for being willing to be on this episode of Bed Back and Beyond. I've been starting a herniated disc treatment options series. So I was so excited to uh to get you on. And because people on the forum are asking for barricade stories. So I really appreciate you taking the time out of your schedule to speak to us.

SPEAKER_04 55:48

It's my pleasure, and thank you for doing what you do. Uh, there needs to be a patient voice out there, uh, not just companies and surgeons. There needs to be a patient voice. Uh, because this is a very real thing you go through. Yeah. Uh that has very real effects. And we're going to try to make them restore you're to your normal life, but uh understanding what's coming is is a

A Barricade Success Story To Watch

SPEAKER_04 56:12

big part of eliminating the fear and optimizing the outcome.

SPEAKER_01 56:19

I actually already have a barricade success story. Back in February, a listener requested that I find someone with a barricade, and Casey was willing to come on and share her surgery journey and how the barricade has helped her get back into weightlifting. You can watch her episode next.