360 PERCUTANEOUS STABILIZATION FOR LOWER BACK PAIN TEXAS BACK INSTITUTE & PLANO PRESBYTERIAN CENTER FOR DIAGNOSTICS AND SURGERY PLANO, TEXAS

Transcription

1 AxiaLIF 360 PERCUTANEOUS STABILIZATION FOR LOWER BACK PAIN TEXAS BACK INSTITUTE & PLANO PRESBYTERIAN CENTER FOR DIAGNOSTICS AND SURGERY PLANO, TEXAS April 25, :00:14 ANNOUNCER: Welcome to the Texas Back Institute and Plano Presbyterian Center for Diagnostics and Surgery. Over the next hour you'll see an AxiaLIF 360 percutaneous 360- degree stabilization for lower back pain. The surgeon removes the center of the diseased disc through a one-inch incision next to the tailbone. The AxiaLIF 360 system combines the stability of the TranS1 3D Axial Rod with percutaneous facet screws to provide a percutaneous fusion and stabilization solution at L5 through S1. The AxiaLIF implant is inserted to distract the two vertebrae, meaning that any height lost from degenerative disc disease is restored to its original healthy disc height. Because this surgical procedure is minimally invasive compared with traditional fusion procedure, recovery time is significantly reduced in many cases. OR-Live makes it easy for you to learn more. Just click on the "request information" button on your webcast screen and open the door to informed medical care. Now let's go to the operating room. 00:01:24 MICHAEL SCOTT HISEY, MD: Good morning and welcome to Texas Back Institute. I'm Mike Hisey. I'm here with Dr. Dan Bradley, and we're going to show you an AxiaLIF 360 percutaneous stabilization of the spine. Dr. Bradley is over at the table getting set, the patient is here, and we're all ready for you. During this broadcast feel free to ask us questions. You can send them by using your MDirect button on your web page. And just click on that and you'll be able to type in your questions and we'll respond to them as quick as we can. Dr. Bradley is here getting started with the patient. She is a 41-year-old female who has had 12 months of intractable back pain, that is back pain that is worsened by sitting, standing, and forward flexion. She has a one-level degenerative disc at the lowest disc in her back, that is the L5-S1 disc space. Can we show Dr. Bradley? And he's going to get started with the incision and get going with accessing the disc space -- 00:02:29 W. DANIEL BRADLEY, MD: Welcome. 00:02:30 MICHAEL SCOTT HISEY, MD: as we discuss the rest of her clinical presentation. Incision is made just a little bit off midline right next to the tailbone. Cut over to the patient's x-rays and show you that she has a relatively good disc height. Dr. Bradley's now spreading the soft tissues. There's a very tough ligament, the sacrotuberous ligament, that it's going to go right next to. And once he gets beyond that he's in a very safe space in front of the sacrum. That space will allow him to have very complete and safe access to the L5-S1 disc space. He's now spreading the ligament, feeling the ligamentous tissues, making sure that he's in the right plane. Prior to coming to surgery, this patient has had greater than a year of aggressive non-surgical care, including physical therapy, oral medications. She has had epidural steroid injections and has had activity modification. Did you want to say something, Dan? 00:03:40

2 W. DANIEL BRADLEY, MD: We're just getting started into the presacral space. I've taken a lateral C-Arm picture if you want to show that to the audience with a probe in place. And you can see I'm just anterior to the coccyx, and what I'm trying to do is develop the fatty plane in between the coccyx and the rectum. 00:03:57 MICHAEL SCOTT HISEY, MD: Can we see the lateral C-Arm? Once he gets into that plane, what he'll do is he'll introduce a blunt probe that will go into a fatty plane in between the sacrum and the intestinal organs. Here's the probe now going into position. And he'll be able to watch that on his intraoperative fluoroscope. To do this operation you -- 00:04:26 00:04:26 MICHAEL SCOTT HISEY, MD: have two fluoroscopes in the room. There should be now a new lateral x-ray available. 00:04:31 W. DANIEL BRADLEY, MD: Can you see that, Mike? 00:04:33 MICHAEL SCOTT HISEY, MD: I'm not seeing it yet. 00:04:36 W. DANIEL BRADLEY, MD: Okay. 00:04:38 MICHAEL SCOTT HISEY, MD: Okay. 00:04:38 W. DANIEL BRADLEY, MD: Let's take an AP picture. Can we orient that? 00:04:45 MICHAEL SCOTT HISEY, MD: And there's the lateral shot showing the probe is hugging the front margin of the sacrum. And as he advances the probe into position, we'll see that he will line up directly with the disc space. 00:04:57 W. DANIEL BRADLEY, MD: And this is just a very gentle back-and-forth motion to dissect up the presacral space. It should not take much force at all. I'll take another couple of shots lateral. And I should be hugging along that anterior border of the sacrum now. 00:05:12 MICHAEL SCOTT HISEY, MD: It is advanced. And you see on the AP view that he's going to try to stay right on the midline. On the lateral view you'll watch him advance and peel the soft tissues forward. Once he gets docked we'll cut to the animation showing really how this looks in a cartoon form. But I think it's interesting and instructive to show what it looks like on x-ray the way we're seeing it in the operating room. 00:05:36 W. DANIEL BRADLEY, MD: AP? And I'm too far off to the side there. I'm going to correct back to the midline. AP. There we go. 00:05:48 MICHAEL SCOTT HISEY, MD: Now he's right on the midline on his AP view. 00:05:50 W. DANIEL BRADLEY, MD: AP again. Lateral. 00:05:54 MICHAEL SCOTT HISEY, MD: Just swapped to the lateral view. 00:05:57 W. DANIEL BRADLEY, MD: Can you bring the C-Arm up a little bit to show me the L5-S1 disc space a little bit better? 00:06:01 MICHAEL SCOTT HISEY, MD: You can see at home that he is lined up with the disc space, maybe just a little bit below it.

3 00:06:07 W. DANIEL BRADLEY, MD: There we go. 00:06:08 MICHAEL SCOTT HISEY, MD: The idea is to get access to that disc and cross the disc space basically at the center of the disc so that he can clean out as much in the front of the disc as he does at the back of the disc. 00:06:19 W. DANIEL BRADLEY, MD: Lateral again. Lateral. Lateral. AP. AP again. 00:06:35 MICHAEL SCOTT HISEY, MD: So it looks essentially perfect on lateral view. And on AP view he'll try and get right on the midline. And once he does he will establish that position with an angled guidewire and stick the wire basically into the bone in the front of the sacrum. 00:06:50 W. DANIEL BRADLEY, MD: Change that out. Thank you. AP. 00:07:00 MICHAEL SCOTT HISEY, MD: Do you like that position, Dan? 00:07:01 I'm going to come up just a little bit from there. 00:07:05 MICHAEL SCOTT HISEY, MD: Yeah, I think it looks real good. You're getting there. 00:07:09 00:07:12 MICHAEL SCOTT HISEY, MD: You can see that in just a few seconds he's able to really get his starting point with very little dissection. You saw the incision, and you can see also that all of what he's doing is being guided by the fluoroscope. There's really no open look at what we're doing. 00:07:30 All right. 00:07:32 MICHAEL SCOTT HISEY, MD: Looks great. 00:07:32 W. DANIEL BRADLEY, MD: Mallet? 0:07:33 MICHAEL SCOTT HISEY, MD: And now the wire will be introduced into the sacrum. 00:07:39 W. DANIEL BRADLEY, MD: Let me see a lateral again. 00:07:45 MICHAEL SCOTT HISEY, MD: Now, as he introduces the wire into the sacrum, this I think would be a good time to go to the animation of the access to the disc space. Could we roll that animation? 00:07:54 AP. 00:08:01 MICHAEL SCOTT HISEY, MD: You can see the probe going into the presacral space, hugging the front of the sacrum as we saw in the operation. You can see how once the probe gets into position, the guidewire is introduced and crosses the disc space. And once the guidewire is in position in the disc space, and not crossing into the L5 vertebral body but just into the disc space, use that guidewire then to introduce larger access cannulas. These tubes will allow the surgeon to introduce instruments into the disc space to allow him to fully clean it out and then introduce the rod, which will provide the final stability. And you can see now the final access cannula being introduced, leaving a tube through which the

4 rest of the operation can be performed. A drill is used then to get to the vertebral body and now we'll watch Dr. Bradley do it. He's got the guidewire in position. 00:09:03 W. DANIEL BRADLEY, MD: Guidewire's in position. We're starting with the first dilator. 00:09:06 MICHAEL SCOTT HISEY, MD: First dilator going in. 00:09:08 W. DANIEL BRADLEY, MD: Just a little gentle back-and-forth motion to free up any soft tissue until you get down onto the bone. 00:09:14 MICHAEL SCOTT HISEY, MD: Yep. Doesn't need to use the mallet until he's up against the bone. 00:09:15 W. DANIEL BRADLEY, MD: All right. Show me a lateral. Good. 00:09:19 MICHAEL SCOTT HISEY, MD: See the lateral view? There we go. 00:09:20 W. DANIEL BRADLEY, MD: And I'm right up there. We're going to be looking mostly under lateral. 00:09:23 MICHAEL SCOTT HISEY, MD: It's perfect. 00:09:29 00:09:32 MICHAEL SCOTT HISEY, MD: He introduces it such that the bevel is all the way into the sacrum. 00:09:41 W. DANIEL BRADLEY, MD: We'll get there. 00:09:42 MICHAEL SCOTT HISEY, MD: Okay. I just want to point out that the anatomic space that Dr. Bradley is working in is about a 2cm-wide fat pad between the front of the sacrum and the rectum, so it's really a quite safe area and very easily dissected. 00:09:58 W. DANIEL BRADLEY, MD: Try that, Bret. Yeah. 00:10:02 MICHAEL SCOTT HISEY, MD: Introducing now the second dilator. 00:10:07 Okay. 00:10:09 MICHAEL SCOTT HISEY, MD: And you can see that there's very, very little blood loss involved in this operation. Second dilator's now in position. 00:10:18 W. DANIEL BRADLEY, MD: And final. 00:10:21 MICHAEL SCOTT HISEY, MD: And now introducing the last dilator and the working cannula together. They go in in one piece and then the final dilator will be removed, leaving the cannula behind, cannula meaning just an open tube to work through. 00:10:44 W. DANIEL BRADLEY, MD: Lateral? 00:10:47 MICHAEL SCOTT HISEY, MD: Tapping it into position with a slap hammer. 00:10:50 W. DANIEL BRADLEY, MD: Let me see the mallet. There you go. Lateral.

5 00:11:07 MICHAEL SCOTT HISEY, MD: And now that he has advanced his working cannula into position, he'll remove the guidewire, remove the dilators -- 00:11:15 W. DANIEL BRADLEY, MD: Your first drill. Okay. 00:11:18 MICHAEL SCOTT HISEY, MD: And that will allow him to introduce his instruments into the disc space to allow him to clean out the disc. 00:11:26 W. DANIEL BRADLEY, MD: We're going to ream through S1. Just through the S1. 00:11:32 MICHAEL SCOTT HISEY, MD: He's now just opening up the sacrum a little bit more, making a little bit more space so that his instruments will go in fully into the disc space. 00:11:42 00:11:46 MICHAEL SCOTT HISEY, MD: And there's -- now the drill in position in the disc. The next thing Dr. Bradley's going to do, then, is to clean out the disc. To achieve a solid fusion, it's very important to clean the disc out as completely as possible. And can you show them the cutter before you put it in, Dan? 00:12:01 W. DANIEL BRADLEY, MD: Yeah. What's a good shot to take this from? 00:12:02 MICHAEL SCOTT HISEY, MD: I think you're good there. Just -- 00:12:04 W. DANIEL BRADLEY, MD: So the cutter - 00:12:05 MICHAEL SCOTT HISEY, MD: There you go. The cutter has a nitinol blade on it with a loop on it. It deploys in a 90-degree fashion and goes in protected in the tube and comes out and then it will spin around. So it will allow you to clean up the disc for a full 3cm-wide disc within the disc space itself. So it's a circle within the disc. And now he's going in into the space. The discectomy is very important in terms of getting it cleaned out. Here's what the cleaned out space will eventually look like, the surface area for fusion, if you can look at it on your web browser. And on lateral view you can see that he has the nitinol wire deployed into the disc space. What this will next do is he turns it around, which will be to scrape off the disc from the endplates, removing the abnormal, or diseased, disc. You can see him doing that. He'll start in quadrants. He'll do it 90 degrees at a time. And then eventually he'll be able to spin it all the way around within the disc space. And he'll work on both the endplate close to the sacrum and on the endplate close to the L5 endplate. We do have an animation showing the discectomy if we could move to that. This discectomy does take a few minutes, and it's important to spend the time, but we can spend that time as well showing you what it looks like on animation. Here's the radial disc cutters with the nitinol wires going into position, you can see starting the front of the disc space and now moving towards the sides. And you can see the debris of the disc being generated by the curved cutters scraping off of the L5 endplate. And he'll introduce now another cutter on the animation. Oh, this is actually a whisk. This whisk will allow you to remove the pieces of disc that you've generated. It's a wire brush, in essence, that allows you to clean out the disc. You can see in the upper right corner the cleaned out disc space. And he'll continue to watch this on imaging just to make sure that he's deploying the cutters within the disc space, not deploying them within the bone. So he has to be careful of that. See on the lateral x-ray that he's in excellent position. Now as you bring that out, Dan, can we see what comes out? 00:14:27

6 W. DANIEL BRADLEY, MD: There's not going to be much come out with this. We'll get that with the whisk. 00:14:29 MICHAEL SCOTT HISEY, MD: Okay. 00:14:30 W. DANIEL BRADLEY, MD: But you can see the cutter has some shreds of cartilage and disc right now, but we'll get the majority of that out in a moment. 00:14:40 MICHAEL SCOTT HISEY, MD: Very good. 00:14:41 W. DANIEL BRADLEY, MD: Short down blotter. Lateral. 00:14:48 MICHAEL SCOTT HISEY, MD: Again, very important to get the disc space as cleaned out as possible. While he's doing that we may go to the animation showing the summary of the entire operation, if you'd like. Describe what we're going to be doing from start to finish. There's a an animation that shows the entire thing. So here's introducing the bone graft material into the disc space. Once he's cleaned out the disc, the bone graft material will go in and he'll deploy it both in the front and the back of the disc space. That's after the disc space is cleaned out using a bone graft insertion instrument. In this case, Dr. Bradley has elected to use BMP-2 combined with Orthovita VITOSS. And we've had excellent result with that in terms of getting a solid fusion. He's continuing to work on cleaning out the disc space. You can see on lateral view that he's cleaning out the center of the front of the disc on this image. You can see that this cutter has a little bit more of a curse to it on the lateral view. This one is designed for cleaning out the endplate closest to Dr. Bradley, that is the S- 1 endplate. 00:16:16 00:16:18 MICHAEL SCOTT HISEY, MD: Whereas there are other cutters designed for cleaning the L5 or farther away from him endplate. 00:!6:25 W. DANIEL BRADLEY, MD: On this particular patient, because of my position, I'm not going to run this cutter all the way around posteriorly. I think it would be too long, so I'm doing more of a windshield wiper technique side-to-side and staying with the short cutters for the posterior. 00:16:41 MICHAEL SCOTT HISEY, MD: Dr. Bradley's pointing out that because of the size of the patient's disc and endplate, he doesn't want to spin that longer cutter all the way around posterior because he doesn't want to go beyond the posterior margin of the disc space. Back there is where the nerves live and the spinal fluid lives, and just as soon leave that all alone. Here's some disc coming out. You can see a large amount of disc is removed from that. Can you get that in the light a little bit more, Dan? There you go. 00:17:08 W. DANIEL BRADLEY, MD: Can you see that? 00:17:09 MICHAEL SCOTT HISEY, MD: A large amount of disc material is removed with these wire brushes and he's going to do this several times to get out as much disc material as he can, because the cleaner he can get the endplates, the better the success rate will be with getting the fusion. And the way these cutters are designed, they work better -- the way the bristles or the brushes are designed -- they work better spinning them counterclockwise. 00:17:39 W. DANIEL BRADLEY, MD: Some more coming out. 00:17:40

7 MICHAEL SCOTT HISEY, MD: There's another large chunk of disc material. And he'll go through this process several times until he's satisfied that the disc is fully cleaned out. I do have a question from the audience. A patient with a herniated disc at the L5-S1 level. Patient's commenting that it is the third time he will have surgery of the same disc. Is this surgery an option for him? Well, in the U.S. this operation is limited to the L5-S1 disc space. There are versions of this that are being developed outside of the U.S. and will soon be available in the United States that would allow taking care of the L4-5 disc at the same time as an L5-S1 disc, but I don't think for a -- for just an L5 correction. I don't think that just for an L4-5 disc it would be appropriate. Another question -- do I -- should I give the names? No. Okay. Another question from Connecticut, a patient with degenerative disc at the L5-S1 level commenting that the doctor wants to do a fusion, but the patient does not want a normal fusion. Patient would like a disc replacement surgery, but her insurance company won't pay for that. And that's often the case that the disc replacements don't get covered. She is looking for more information on the TranS1 procedure and how dangerous it is. Her doctor doesn't want to do the TranS1, saying it is too dangerous. Actually, in inexperienced hands any operation could be dangerous, but this operation is very safe. I can talk to you about complication rates, but it turns out to be in the less than 1% range for the TranS1 procedure, which compares very favorably to any other technique of achieving a fusion, so I would say that this operation is very safe. And if you have an isolated L5-S1 problem, this is an excellent option for you. Another question from Nevada, a patient with degenerative discs at more than one location. Would this procedure be of help to him? Patient has spinal stenosis also. Multi -- this is primarily for the L5-S1 disc. It can be combined with other operations to address other discs such as perhaps a TLIF or something like that at the L4-5 level or an extreme lateral interbody fusion at the L5 -- at the L4-5 level to achieve a fusion. A stenosis decompression might be a separate procedure. It really depends on the specifics of the case. But often a stenosis decompression is a separate portion of the operation. If the patient's stenosis is due to deformity such as a spondylolisthesis, it may be that this can reduce the spondylolisthesis and take care of the stenosis at the same time. So if that addresses the Nevada question. Let's see how Dan is doing with the discectomy. He continues to work with the cutters cleaning out the disc space. This is now another brush in place whisking it out. Another large chunk of disc delivered from the disc space. 00:20:56 W. DANIEL BRADLEY, MD: Thank you. Show me a lateral. 00:21:08 MICHAEL SCOTT HISEY, MD: Now, as Dan continues to clean out the disc, if we could look at the slide of some information on the procedure itself and the complication rates. To address the question again from Connecticut, you can see that the average OR time for an AxiaLIF is lower than any other technique of interbody fusion. The blood loss is lower. You can also see that the complication rate is lower and that the length of stay -- LOS means length of stay, or how long a patient stays in the hospital. That's also lower. The patient's in the hospital on the average of about one day. This patient may choose to go home today, the one we're operating on today. May choose to go home today but may stay till tomorrow, and that would be fine either way. But you can see from this data that the -- that the complication rate is quite low. And this is not just one doctor's impression. There have been several studies that have reproduced the data done by the initial. That is, Dr. Pimenta out of Brazil did the first series of cases, but it's been reproduced on several occasions getting similar complication rates and similar excellent results. 00:22:24 W. DANIEL BRADLEY, MD: Let me just have the long radial. Uh-huh. Thank you. Lateral. 00:22:36 MICHAEL SCOTT HISEY, MD: And Dan continues to clean out the disc. You can see that the cutter is now up against the super-- or the inferior endplate of the L5 vertebra.

8 00:22:56 W. DANIEL BRADLEY, MD: All right. Another brush, please. Are we almost ready with the bone graft? 00:23:04 MICHAEL SCOTT HISEY, MD: Again, this is the most important part of the operation, getting this disc very well cleaned out. Another question from a patient who sounds similar to our patient on the table today, a 41-year-old white female who doesn't want to have -- whose doctor doesn't want to do a fusion until she turns 50. Can this procedure be done at her age? Well, obviously we're doing a patient who's 41 years old today, so we believe it can. What is the percentage in having this done? Oh, the percentage of success rate on this is about 90 to 92% successful, so it's a very successful operation in terms of achieving fusion and in terms of achieving the pain reduction that you're looking for. Nothing's 100%. And I would say that the rationale for not wanting to do a fusion until you turn I don't think there's any magic to any particular age, but you certainly don't want to rush into a fusion operation. A fusion operation is not something you should have for back pain that you've had for several weeks or even a couple months. It should be for pain that's persistent and debilitating. A fusion operation is not a perfect end-all operation. You do lose something. You do lose some motion. But in patients who are hurting enough, it is a very good option for them. "Would the AxiaLIF procedure be used on an otherwise healthy 38-year-old male who has moderate large central and left-sided disc protrusion at the L5-S1 level?" It really depends on the symptoms. It certainly could be used on that patient if they had had the right type of symptoms, that is, back pain that has been debilitating over the past six months to a year. If the pain's primarily nerve root pain, that is, compression of the nerves, it may be that a smaller operation such as a mini decompression could be used to remove the pieces of disc that are compressing the nerves. Maybe a little smaller operation might be of benefit to a patient like that. Really depends on the symptoms. And the next question is, "How much mobility with the patient have with bending, and the ability to sit, stand, and walk for any length of time?" Hopefully with a successful result to the operation she'll have very little loss of motion. You do have some motion at each disc space, of course, but there are five discs and most of your motion when it comes to flexion and extension comes from your hips. Much of the lateral bending and twisting does come from your back, but you will lose a small percentage of that. So there will be some loss of motion, but hopefully the patient will be able to sit quite comfortably, walk, and participate in all activities. 00:25:38 W. DANIEL BRADLEY, MD: Mike, I'm going to be bone grafting. 00:25:39 MICHAEL SCOTT HISEY, MD: Okay, so Dan has now completed cleaning out the disc and he's now getting to the bone grafting. So we've seen the animation on that and now we're going to watch him put the bone graft in. Again, this is a combination of BMP-2 and VITOSS. We're going to watch the bone graft go in on lateral view. There's the bone graft inserter with the angled tip, so he's able to direct the bone graft first towards the front of the disc space where he's cleaned it out and then he'll rotate it around and direct it throughout the entire disc. 00:26:07 W. DANIEL BRADLEY, MD: All right. VITOSS? That's fine. So what I did was put the MPs in first and then we're going to backfill with the VITOSS. 00:26:22 MICHAEL SCOTT HISEY, MD: So he's got the BMP, which is a recombinant product that stimulates bone formation, and then he'll give it a scaffold to form around with the VITOSS. 00:26:34 W. DANIEL BRADLEY, MD: And what I did was did a bone marrow aspirate to begin with and mixed that with the VITOSS. 00:26:42

9 MICHAEL SCOTT HISEY, MD: So he's packed the VITOSS -- or he's packed the BMP, which is attached to a collagen sponge, he's packed it in the outside of the disc space. And now he's packing the VITOSS in around that to compress it towards the outside and to hold everything into position. Here goes the VITOSS. A little impactor to push that in. 00:27:12 There we go. Lateral. There we go. Lateral. And I'll take the drill. That's enough for now. Lateral. 00:27:46 MICHAEL SCOTT HISEY, MD: Now as the drill is going into the next -- he's got the bone graft all in position. Now he's going to drill into the L5 vertebral body to make room for the axial rod. Changing his angle a little bit. I want to point out that he is leaving as much of that patient's anatomy intact as possible. The way the disc is built is basically like a radial tire with goo in the middle and it has fibers on the outside, and those fibers are all left intact with this procedure. All you're taking out is the diseased central portion of the disc. So the patient's natural anatomy is left as intact as possible. This is the least invasive way of accomplishing a fusion. You can see now that he's drilled into the L5 vertebral body. And he'll follow that then with the axial rod. And he'll have to choose a size, which he'll measure now. He's using this wire to help him determine the proper size of the implant to be placed. And when that implant goes in, if he want it to he can put it in in a mode that will distract the disc space. 00:29:02 W. DANIEL BRADLEY, MD: How about a 45? 10 x :29:08 MICHAEL SCOTT HISEY, MD: Now he's choosing his implant. He's selected a 45 10x11 implant, and that describes the length of the implant and the two different thread pitches of the implant. This one gives minimal distraction, as opposed to others. Because the patient has a tall disc space to begin with, he does not need to distract her very much. In a patient with a more collapsed disc space, you might see an implant with a greater differential in the thread pitch, and that would allow distraction. We'll show that on an animation in a second after he gets the implant in place. Now he's exchanging his tubes now to allow a slightly larger tube to be in position. What he wants is a tube that is not in the sacrum any longer, one that's just docked up against the sacrum. That'll allow him to then introduce the implant into position. 00:30:19 00:30:20 MICHAEL SCOTT HISEY, MD: What he wants to do is protect the soft tissues anteriorly as he puts in the -- yeah -- as he puts in the implant. 00:30:30 W. DANIEL BRADLEY, MD: Let's try the 30. Outside sheath. 00:30:33 MICHAEL SCOTT HISEY, MD: Can we go to the distraction animation as he's getting his implant ready? And here's the -- when the implant goes in, you drill into the L5 vertebral body. And the implant has threads that are different on each side. The threads are of different pitch such that when you tighten the implant into position, it will advance and push the L5 vertebra away from the S1, creating more space in the disc space. And this is the inserter that he has already put in place going into position, removing it, and then over the guidewire the implant will go into position. You can see as the implant goes in, it will distract the disc space, elevating the disc back to its normal height. 00:31:23 W. DANIEL BRADLEY, MD: Mike, I'm going to tack this down with a little stay wire. 00:31:27

10 MICHAEL SCOTT HISEY, MD: Okay. He's going -- can we go to -- once the animation's through? Dan has a little wire that he's going to use to hold his tube into position to keep it from sliding as he completes the insertion of the device. Please recall -- remember that you can be free to send in questions using your MD Access button, MD Direct Access button on your web browser. We'd be happy to answer any questions that you come up with. You can see on this lateral view that immediately behind his instruments is a very thin wire. That's what's holding his guide in place and will keep it from sliding out of position as he introduces the final implant. 00:32:09 00:32:11 MICHAEL SCOTT HISEY, MD: And here comes the implant. You can see the threads on the device going into -- beginning to be present on the view. 00:32:17 W. DANIEL BRADLEY, MD: Say that again. 00:32:19 MICHAEL SCOTT HISEY, MD: Oh, I'm just pointing out the threads on the implant. 00:32:22 W. DANIEL BRADLEY, MD: Gotcha. Lateral. 00:32:30 MICHAEL SCOTT HISEY, MD: He's bent his guidewire out of position so it doesn't bother him as he advances the implant. And you see the implant now crossing the disc space. Once it crosses the disc space and introduces itself into the L5 vertebra, he'll be able to remove the guidewire. And this gets to be a little tight. You know, with a patient with good bones such as her, he's going to be working pretty hard getting this in. Might be fun to cut to a shot of Dan and watch him sweat a little bit. 00:32:54 W. DANIEL BRADLEY, MD: Hey. 00:32:59 MICHAEL SCOTT HISEY, MD: Ah, maybe a little grunt there. He's working a little bit. It's looking great, Dan. He gets the guidewire out once he's into the L5 vertebra. And he checks -- he's got a look at both x-rays as he's doing this operation. 00:33:15 AP. 00:33:23 MICHAEL SCOTT HISEY, MD: And the device lines up very nicely on the midline. And he's going to watch to make sure that he gets it introduced such that the threads are all the way into the L5 vertebra and that the threads at the bottom of the implant are buried with the sacrum. So he's been working on this about 35 minutes now and has already accomplished the front half of a circumferential fusion. Very little blood loss. Very, very little soft tissue destruction. 00:33:53 W. DANIEL BRADLEY, MD: I think I'm going to leave it there. 00:33:55 MICHAEL SCOTT HISEY, MD: And now he does not have to turn the patient over to get the back part of the operation done. There's a question from the audience asking, "Is there any severe internal bleeding in this operation?" No, there really isn't. We avoid all of the big blood vessels. There's a slide I can show that will demonstrate the anatomy. You can see on this slide that what we do is we stay in between the big blood vessels. There are big blood vessels that come down from the heart and branch off towards the legs, but they have branched and divided by the time we get down to where we are. There are actually very few blood vessels in the front of the sacrum. This is a very safe area to be. Another question is,

11 "What kind of anesthesia do you use?" These patients are all fully asleep with general anesthetic. She won't remember this operation at all. 00:34:44 W. DANIEL BRADLEY, MD: AP. 00:34:48 MICHAEL SCOTT HISEY, MD: Dan's checking the AP, just checking the final position of the implant now that his guides have been removed. And it looks great, Dan. 00:34:53 W. DANIEL BRADLEY, MD: Yeah, I like it. 00:34:54 MICHAEL SCOTT HISEY, MD: Nice job. 00:34:56 W. DANIEL BRADLEY, MD: All right. Now we're going to get ready for the other half. 00:34:56 MICHAEL SCOTT HISEY, MD: So now he's done the front half of the circumferential fusion, or the front-and-back fusion. But 360 what we usually mean is we have to rotate the patient on the table like they're on a spit on a barbecue grill, but we don't have to do that this time because she's laying on the table in the position she needs to be in. So we're not going to need to rotate here. So we're saving time in the operation, saving anesthesia time for her by doing it in this position. Dan is now going to get ready to put in the percutaneous facet screws. 00:35:29 W. DANIEL BRADLEY, MD: I'm going to change gloves, too. 00:35:33 MICHAEL SCOTT HISEY, MD: And to show you an example of what it's going to look like in the final construct, I have a -- oh. As Dan prepares for the TLIF, what he's doing is he's draping out the area where he's already operated. He's going to get that incision out of the field. And now he's going to work a little higher up on the patient's back, working down from about the L3 level to get the proper angle down to the L5-S1 facet joints. I was asked a question about a 47-year-old female who was diagnosed with stenosis at the L4-5 level and spondylolisthesis at L5 with degenerative changes in all lumbar discs, all show with herniations above. I guess her surgeon would not do an ablative operation for stenosis or a laminectomy without doing a spinal fusion. Would this procedure be a better option for her, and does this procedure reduce the latter effect on other vertebrae? She's had pain for two years. Well, it sounds like she's certainly had pain long enough for it to make sense to do some sort of a surgery. Spondylolisthesis, this operation is very good for spondylolisthesis, and it's possible to do it in a multilevel case such as hers if we did the AxiaLIF at the L5-S1 level, combined sometimes with a mini-open or a minimally invasive TLIF type procedure at the L4-5 level, allowing us then to decompress the spinal canal at that level. So it can be combined with other operations. This operation by itself for a multilevel problem wouldn't do it, but this can be combined with other procedures to keep within the minimally invasive philosophy and get the patient an excellent result. Now, to comment on the slide showing -- this is -- the slide shows a patient with a rather collapsed disc, and you can see that the axial rod has been introduced and has distracted the disc space. And you can see the facet screws in position, stabilizing the patient from posterior. This is done through a very, very small incision. 00:37:33 W. DANIEL BRADLEY, MD: All right, Bret. Let's see AP. 00:37:39 MICHAEL SCOTT HISEY, MD: And Dan now is marking his spots to get his proper alignment. 00:37:41 W. DANIEL BRADLEY, MD: We're going to go up a little bit, Bret, to L3. Yeah. 00:37:47

12 MICHAEL SCOTT HISEY, MD: As Dan's getting his landmarks, if we could look at the 360 animation to describe the completion of the procedure. 00:38:00 W. DANIEL BRADLEY, MD: AP again. 00:38:02 MICHAEL SCOTT HISEY, MD: Meanwhile, Dan's getting his landmarks. Now, once you've completed the introduction of the rod, you can actually put in more bone filler if you'd like. You press it into position. You can then plug up the hole in the axial rod that you -- that the guidewire used to be in. And once you've done that, you go ahead and put the facet screws in place. 00:38:27 W. DANIEL BRADLEY, MD: All right, Mike. We're going to get started. 00:38:29 MICHAEL SCOTT HISEY, MD: Okay. 00:38:29 W. DANIEL BRADLEY, MD: Make a skin incision. 00:38:31 MICHAEL SCOTT HISEY, MD: This case shows a pedicle screw construct. That's not exactly what we're doing. We're going to do a facet screw type construct. Dan's made his incision on the midline at about the L3 level as he's identified it on AP view. And what he'll do is he'll introduce a blunt guide down towards the facet joint of L5 and he'll cross that L5-S1 facet joint with a small wire. And then over that wire he'll place the screw. 00:39:02 AP. 00:39:09 MICHAEL SCOTT HISEY, MD: Dan's beginning on the patient's left side. 00:39:11 00:39:15 MICHAEL SCOTT HISEY, MD: You can see it in that overhead shot that it's just a very small skin incision. And there he is docked up against the L5-S1 facet joint. 00:39:24 W. DANIEL BRADLEY, MD: Both. 00:39:28 MICHAEL SCOTT HISEY, MD: Once again it's into a position that he likes. What he'll do is he'll pass the small guidewire across the joint. And it takes very small -- small movements of his hand to make these corrections. The idea of the facet screws is to add a little bit more rotational stability and a little bit more flexion-extension stability. Though the axial rod by itself is a very strong construct, it is not specifically labeled for use by itself. There's an AP view showing, again, the guide in position over the L5-S1 facet joint. What he's doing is tapping it into position now so it doesn't skooch around on him. 00:40:17 W. DANIEL BRADLEY, MD: All right. Pliers. 00:40:25 MICHAEL SCOTT HISEY, MD: And once the guide's in position, he'll introduce a wire across the joint. 00:40:32 W. DANIEL BRADLEY, MD: Mario, can you come up top? 00:40:41 MICHAEL SCOTT HISEY, MD: He's removing now the wire that was basically used to keep the cannula from being obstructed by bone. 00:40:50 W. DANIEL BRADLEY, MD: Thank you.

13 00:40:58 MICHAEL SCOTT HISEY, MD: Now what he's trying to do is increase the stability of the spine in multiple degrees of freedom. When you compare the axial rod by itself to the axial rod -- to facet joints by themselves, you can see how on this anima--on this PowerPoint slide that he does increase the stability quite significantly, and then when you combine the whole thing together, it really is quite excellent in terms of achieving stability. Now he's drilling across the facet joint. 00:41:28 W. DANIEL BRADLEY, MD: Keep going. You've got to go all the way through. Keep going, keep going. 00:41:33 MICHAEL SCOTT HISEY, MD: Using a high-speed, air-drive drill. 00:41:34 W. DANIEL BRADLEY, MD: Stop. Let's take a shot. AP. 00:41:39 MICHAEL SCOTT HISEY, MD: There's the wire across the facet joint on AP view. 00:41:43 W. DANIEL BRADLEY, MD: Okay. Yep. 00:41:54 MICHAEL SCOTT HISEY, MD: And once he has the wire across, the next step would be just to put a slightly larger tube in place so that he can deliver the screw through the tube. And there it is. And now he'll select his screw and pass it across the facet joint. And then he'll be able to accomplish the same thing on the opposite side using a -- using the same incision. Once he has the guidewire in position he'll drill a pilot hole for the screw so that the screw will pass easily in through the facet joint. 00:42:46 W. DANIEL BRADLEY, MD: If you'll hold this here for me. 00:42:50 MICHAEL SCOTT HISEY, MD: She feel like she has pretty normal bone density, Dan? 00:42:52 W. DANIEL BRADLEY, MD: She does. Lateral. Okay. 00:43:05 MICHAEL SCOTT HISEY, MD: Lateral x-ray, please? Now that he's drilled his pilot hole he's going to hold the guidewire in place, making sure that he doesn't lose that. 00:43:21 W. DANIEL BRADLEY, MD: Here you go, Mario. Thank you. 00:43:24 MICHAEL SCOTT HISEY, MD: And then introduce the screw over that guidewire. Okay. After he introduces the screw we'll go through the animation of the entire procedure then. 00:43:38 W. DANIEL BRADLEY, MD: All right. Screw. All right. Mario, can you help load that for me? 00:43:53 MICHAEL SCOTT HISEY, MD: The way he's directed the screw is essentially a facet pedicle type screw. It gives him very strong purchase into a very good, strong portion of the S1 vertebra. And he's now introducing the screw into position over the guidewire. And the final step will be to remove the guidewire and then begin on the opposite side. You may be wondering how you take care of the skin incision way down low like this axial rod requires. But we close the incisions using Dermabond and sutures underneath the Dermabond, and with that there's not even a dressing that you have to worry about as a patient, so it's very easy to take care of once you get home after this operation. Now you can see the screw in excellent position, crossing the facet joint, adding extra stability. And now the guidewire's been removed. Now, if we could go to the -- that's the AP view. We can go to the animation. Very lifelike animation -- oh, there we go. This is the facet screw instrumentation. Once

14 you've done your anterior procedure, you use a guide pin introducer to then enter through an incision a little bit above the level where you're interested in working at an oblique angle crossing the facet joints. So you're basically trapping the L5 facet joint against the S1 -- the inferior portion of the L5 against the superior portion of S1. Tap it into position so it doesn't slide. Introduce a guidewire over the wire driver. Crossing the facet joint. Our marker's on the guide wire, so you know just how deep you're going. Use the slightly larger dilator so that you can introduce your drill. These instruments are, by the way, very analogous to the instruments you use for the axial -- for the anterior portion of the procedure, so it's very intuitive to use the instruments in the same fashion, same sequence. Once your guidewire's in position you drill over it into the facet joint to 30 mm. And the last thing you'll do is you'll tap -- if you desire, you don't always have to -- then introduce the screw into position using the screwdriver. Tighten it down. 00:46:50 W. DANIEL BRADLEY, MD: Go collinear. Keep going, keep going, keep going. 00:46:52 MICHAEL SCOTT HISEY, MD: Final tightening and it opposes to us. 00:46:55 W. DANIEL BRADLEY, MD: Stop. Lateral and AP. 00:46:56 MICHAEL SCOTT HISEY, MD: All the instruments are -- there are few enough instruments in this set that all of them can fit on one Mayo stand, if you know what that means as a surgeon. That's very few instruments. The scrub techs really like these operations because of the low load on their back carrying the instruments around. It is a truly percutaneous front-and-back fusion with very minimal destruction to soft tissue to access the facet joints. Let's cut back to Dan, and he was already well on his way to getting the right-sided facet joint instrumented. He's got his cannula in place. He's introduced the guidewire. And he's now getting ready to drill across the facet joint. Again, feel free to ask any questions you might have. Looks like he's moving so fast that we're going to have a little bit of time at the end of this broadcast for any questions that might come up. 00:47:49 00:47:54 MICHAEL SCOTT HISEY, MD: Very much parallel to his previous screw placement. Very nice, Dan. That's AP view showing the drill in position. 00:48:12 W. DANIEL BRADLEY, MD: Little bone graft. Thank you. 00:48:20 MICHAEL SCOTT HISEY, MD: He's introducing some bone graft. He's drilled into the facet joint and he's now introducing some bone graft into the facet joint to help with the facet joint fusion. And the screw going into position. This'll be the final screw. Another question that's often asked is how long is the patient in the hospital. Typically the -- on the average, the patient's been in the hospital 1.1 days. As I said, this patient may go home as early as this afternoon if she wants to. There's really very little that would keep her in the hospital. We have not disturbed her intestines, so she should be able to eat right away. We've done very little muscle destruction, very little damage to any of her soft tissue, so she should be very comfortable after this operation is over. And hopefully her preoperative pain will be much improved. Lateral view showing the screws going into position. Another question that's often asked is how long will it be until this patient can return to work. And a lot of that depends specifically on what the patient does for work. If she's in a heavy-lifting or industrial job, she'd want to wait until her fusion was pretty well on its way to healed, which can take a few months. But if she's at a light-duty or a desk job, she might be able to go back to work as soon as the end of this week or early next week. As long as she can be

15 sensible about restricting herself to some degree. She'll be able to get up and walk as soon as she's awake. 00:50:12 W. DANIEL BRADLEY, MD: All right, do you want to center those up, Bret? 00:50:16 MICHAEL SCOTT HISEY, MD: Now the instruments are all in, the screws are all in. And we can have a look at that incision. Very small incision. You can barely see it up at the top of your screen. It's taken 46 minutes now for Dr. Bradley to accomplish this fusion front and back. And it's all over but the skin closure. In fact, he's done so little damage inside that he doesn't have to close anything really but the skin. Any comments on the trajectory of those screws, Dan? Did you feel like it was pretty routine? 00:50:46 W. DANIEL BRADLEY, MD: Pretty routine. One of them -- the patient's right-hand side obviously started a little bit lower, so it looks lower on the lateral, but pretty routine. Had good bite across. Good distraction across the disc space with the axial lift rod. 00:51:02 MICHAEL SCOTT HISEY, MD: Looks great. Very nice-looking result. 00:51:12 W. DANIEL BRADLEY, MD: All right. No, I think those are good, Bret. 00:51:18 MICHAEL SCOTT HISEY, MD: So at this point we can go to look at some of the results that we've had with this operation. What have we got here? There have been some studies done looking at patients 30 months after the procedure looking at the safety, reproducibility and validity of this operation, and the patients have done very well. 26 patients at 30-month follow-up, average age of about 51 years. 19 of those patients -- well, the patients all had minimal post-op pain. In this study, a length of stay was about 1.9 days, although I think that's really come down. And the mean surgical time has come down as well. The mean surgical time used to include a percutaneous pedicle screw type construct, and sometimes we still can use that in a patient with instability such as a high-grade spondylolisthesis or something like that, but in a patient with primarily a degenerative disc disease, the percutaneous facet screws are very adequate for giving good fixation. And it's a much less destructive, much less damaging, much less invasive procedure to get that done. The patients do have very good improvement of their pain scores. They improve about or, sorry, about 65% on their visual analog scale. Their CT scans do show excellent fusion rate. At two years, 93% have fused. At one year, just under 90%. And none of them have motion with flexion or extension. They're getting final films of the patient now. In terms of complications, infections are -- infections are exceedingly uncommon. No reports of vascular injury that I know of. No neurologic injury. No re-operations in this particular series. No evidence of implant backout or migration. These patients really just do great. They're getting ready to close the skin. Now, looking at the patients' pain scores, comparing standalone procedures to -- This operation has been done as a standalone procedure, and the standalone procedures have tended to do as well as the nonstandalone, although this device, that is, the axial rod, is not labeled for standalone use. It is labeled for use with supplemental posterior fixation. So use of it by itself is considered an off-label indication, but still has been done with significant success. Some case examples. One of the patients that I thought was the biggest home run is not this one in the film but has similar qualities, that is, a patient with markedly degenerative disc at the L5-S1 level and calcification of the blood vessels anteriorly. That keeps you from being able to go from the front of the spine to access the patient because if you have those calcified blood vessels, you can cause those calcifications to dislodge and cause problems with the blood vessels in the lower extremities. In cases like this, the axial rod is an ideal solution to enter the disc space, distract it, and indirectly decompress the neural foramen. Patients should have -- patients that are indicated for an AxiaLIF should have appropriate presacral anatomy. That is, no history of

16 inflammatory bowel disease, which might cause sticking of the bowels to the sacrum. But other than that, really there are very few contraindications. This procedure is indicated for patients with L5-S1 disease primarily. Dan's now closing up the incisions. And they look much bigger on the -- on the zoom than they are in real life, but that's really about -- how - - do you want to put a ruler next to that, Dan? 00:55:25 W. DANIEL BRADLEY, MD: Yeah, you got a ruler for me? 00:55:29 MICHAEL SCOTT HISEY, MD: See how big an incision we're talking about. 00:55:34 W. DANIEL BRADLEY, MD: Here you go. So 1-1/2 cm. 00:55:40 MICHAEL SCOTT HISEY, MD: Centimeter-and-a-half incision for the facet screws. So that's a posterior instrumentation and fusion through a 1-1/2-cm incision. Patients -- I'm going to show an example on the slides now of a patient with multilevel disease. This is a patient who had a degeneration of the L5-S1 as well as at the L4-5 level, and in this patient a minimally invasive technique using an axial rod at the L5-S1 level combined with a TLIF type construct, which is a transforaminal lumbar interbody fusion type construct, at the L4-5 level was used, and it was supplemented with percutaneous pedicle screw fixations. So all of that was done through several very small incisions, again with minimal bone destruction, no detachment of any muscles from their origins or insertions. The patient is now one year after surgery and is back to work full-time as a firefighter. Was on a desk job prior to the surgery, now is back to waterskiing, back to motorcycling, and now reports a 0 out of 10 pain score in both his back and his legs. So he's done very well. There's another interesting case of a patient who had had a previous fusion at the L5-S1 level using a TLIF-type technique. And once that -- this is not it? Oh. Yeah. Had a TLIF-type technique. I'm sorry. I'm showing the wrong films. Had a TLIF-type technique, had not healed, and was revised or salvaged with a TranS1 procedure. 00:57:35 W. DANIEL BRADLEY, MD: Okay. The inferior incision is just over 3 cm here and I made it a little extra generous, but that's about a normal size. And we'll close that again. We'll put some Vicryl in the fascial layer and a little subcutaneous stitch, and then this incision we will cover up with the Dermabond and not put a dressing there. We'll put a small dressing here up top. But you can see just a very small two-incision technique. Very little tissue trauma. These patients do very well. She'll be up walking around later on today. 00:58:12 MICHAEL SCOTT HISEY, MD: So Dan's now closing up the axial rod incision. Again, feel free to to text message any questions you have using your button. Oh, so let me -- you show that case again. The patient that had had the TLIF had not healed and was revised with the axial rod. The patient had screws removed -- the patient had back pain post -- after surgery. So this is really a worst case scenario, like what's the worst thing, hardest, most difficult case you can have with a TranS1 rod. And they were able to clean out the back of the disc space, place bone graft within the disc space, achieve a successful fusion, remove the patient's posterior hardware to get rid of that pain, and the patient really had an excellent result with good, solid bone formation. And at six months' post, very good, solid bone within the disc space showing signs of fusion anteriorly. We have a sign that we call a sentinel sign, where you see a nice bridging sheet of bone anterior to the instrumentation. That's the sign of an excellent result. And Dan's getting the skin all closed up there. Are you going to close that with some Dermabond, too, Dan? 00:59:56 W. DANIEL BRADLEY, MD: Yeah. We've had very little complications here at TBI. Superficial wound issue. More likely it was irritation from the Vicryl than anything. Treated with some local wound care and a short course of antibiotics. Cleared up just fine.