Welcome, good evening, thank you for joining us. The presentation will run around 45 minutes, and the last 15 minutes of the webinar will be dedicated to Q&A. Before we begin, I'd like to review some housekeeping items. This webinar is being recorded and live streamed. A recording of the webinar will be made available in the Aug eLearning portal. Please use the Q&A feature of the Zoom webinar to ask the speaker questions. We will answer them at the end of the presentation. Use the chat feature if you have any technical issues, and Aug's staff will be monitoring the chat and can assist if needed. Thank you, I'll turn it over to you, Dr. Walton. Thank you, Shelley, I'll share my screen now. Good evening, everybody. I'd like to thank Aug's for an opportunity to present tonight, and really the webinar is a beautiful way for us to share and exchange information. For me tonight, success will be defined as the ability for me to answer questions and have a really interactive session. So I am really going to try to stay on time with getting through the slides, but I encourage you to please put your questions into the chat or into the Q&A. Again, my name is Dr. Brianna Walton. I am a board-certified Eurogang out of University of Maryland, Capital Region. I've been in the DMVD area for many years now. I'd like to thank Holoplast for compensating me for my time, and I will absolutely be personalizing this presentation, as you should expect. Anyone who has been in our field for any period of time should not only discuss the evidence, but should discuss their experience. So I will be doing that. I would also encourage you, if you are interested in more information, because this data is really meant to add to our knowledge and to extend information to our patients, I would encourage you to contact Shelley. There's a few things that you can actually do. One is a case observation, if you're actually thinking about doing the ALTIS sling. If you are a fellow or a resident, you can actually come to Minnesota. We have a fellows lab coming up, and it usually proves to be a really insightful and helpful event, not just in the technical aspects of performing slings, but just some of the exchange of information between the panels. And then finally, if you want to stay up to date on what ColoFast has to offer, you have the other QR code at the top of the screen. Tonight, I'm really going to touch on four really basic topics. As I walk through, I really want to tell the history of who we are, what the mesh is like, what the data shows, and then some of the key features. And then we're going to jump into the questions. So we always start, now I apologize, if anyone has heard this slide deck before, I try to make it a little more interesting each time I talk about it. But the take-home message is that we have a condition that we care for that is highly prevalent. We have a condition that is undertreated when we know that about 53 million women in the United States are suffering from either stress incontinence or mixed incontinence, and yet only about 1% have surgery. And if you look at the parallel data in terms of implants and concerns about mesh and materials, our cataract surgeries, they're doing about 3.7 or 7.3 million a year. If you look at hips and knees, it's about two to 4% of people actually have surgery for these conditions. These conditions though, they may not cause pain or cause visualization issues. They really do affect quality of life. Women start to alter their sexual patterns, their voiding patterns. So it's not just an inconvenience. So we know, I'm preaching to the choir tonight, we just haven't been able to penetrate in the way that we want. So the question is why? I think part of that is our history. If we look back at what we tended to offer in the 1914 era or 1910, Howard Kelly described his puborethral ligament placation. This was a repair that really stood the test of time for almost 50 years until we started doing more retropubic suspensions with the Birch and the MMK. These procedures stuck around for 30 years and it was one of the first procedures I was actually trained on while I was in fellowship until about 1994 when retropubic slants really entered the field with no apology that they were a potential way to actually not just suspend but stabilize the urethra based on Olmstead's theory. So retropubics, which I think have been a game changer and many of us out in the audience have been diehard retropubic users for years, were phenomenal at predictable placement, predictable outcome, but with the unfortunate advent of actually sometimes ending up in the wrong spaces and places and causing some very untoward effects. So as we know, there might be an increase or there is an increase in visceral and vascular damage. We migrated to trans-obturators in order to try to avoid that retropubic space. But as a trade-off, an unfortunate clinical trade-off, we diminished our visceral damage and we increased our groin pain and some really significant outcomes. I think many slings were actually, there was a halo effect because we were so happy with what we were doing with our mid-urethral slings. But unfortunately, the first to market, which was the TVT Secure, and I don't know how many of you have actually seen the design or held it in your hands, was a very different product than what's on the market now. These were slings that were more of a pledget-based system that you would just wedge into either a trans-obturator or a retropubic, you had choices. And that wedging was not necessarily specific. And so as the information and the data came out about TVT Secure, we started seeing a migration away from it because it was clearly inferior based on multiple studies. And so the positive halo effect of slings which was persistent until we had many slings started to change when many slings hit. And for that reason, I personally did not want to do a mini sling. I went back to my retropubic sling and stuck with it for many, many years. But in 2007, anchor-based slings were introduced by AMS, which we said, you know, we're not trying to wedge our material into just the obturator space. We wanna anchor it into that space. And slings were created in order to anchor it to the obturator and internist. Adjustable slings, which were first submitted by BARD were also in that similar vein, but the ability to adjust it, and it's a very similar model or comparison to the current state ALTIS. BARD is not available here in the United States, but it has been used in Europe and abroad. It was 2012 when ALTIS was actually able to introduce their product, which is different in several ways. And so I wanna explore that with you tonight. So let's first talk about the family of ALTIS products or Coloplast products and particularly their sling, because this was why I ended up actually using. Many people have made transition to a single incision sling, but many have had different reasons for going to a single incision sling. For me, it was always about the material. When you look at this material, it looks very different. If you feel it in your hands, you know it's different than the current elastic or more elastic material that's out there in terms of polypropylene. And when I first heard that this was really a purposefully designed mesh, I really thought, well, this is a marketing tool. But as I started looking at the data, which I have become more and more interested in some of the biomechanics of this material, in addition to some of the clinical outcomes. So this is our level three support. It is meant to stabilize. This is meant to be a supportive area just under the urethra. So where we, over time, started migrating away from the pubourethral ligament, we've come back. We know that this is a critical structure in terms of the Olmstam theory. How do we know this? So there are several studies that are out there. Some are simulations and some are actually biological models. I really like this particular slide and I'm going to explain it to you. So if you look at the non-hatched lines, the one in dark blue represents the pubourethral ligament. And as you apply force to it, you will see the ability for that tissue to strain. This blue line represents the pubourethral ligament. Then we have the vagina and the rectum, down here, fascia, and then pelvic floor muscles. So as you see, we go down, you have more elasticity of that tissue. When you compare, and this is an overlay of Pamelaoui's study in 2008, when you compare the biomechanical properties of the ares or the coloplasm mesh, which they're all the same, it performs more like that pubourethral ligament as opposed to other tissues. So this kind of got me started thinking, but I really didn't pay attention to this. What I paid attention to was, I was worried that it was a smaller pore size. I was worried that I was going to get more infections. I was concerned about the possibility of encapsulation, probably like you. But this is an AMID Type 1, and it does have a large pore size by criteria to allow macrophage and neutrophil intervention to actually prevent infection. At the bedside, when I was in a room with a patient, as I began to start to apply my own biomechanical forces to the material, I started to say, wait a minute, maybe there is something here. So I was a fairly dedicated elastically model. I've used both, almost every single product out there on the market. And if you look at the top side, where you see no force, now that pore size is definitely wider. But then as you begin to apply force, you will see a change or a deformation in the characteristics of elastic materials, where you don't see it in the coloplast family. The concern we also have, and perhaps this is part of the reason why we see, you place a sling and you know you've done it in the right way. And why, if you had to go back to release a sling, does it look the way it does in terms of cording or banding? It's the inability for these things to recoil to their natural state. And that can also affect pore size and the ability for tissue infiltration. So it was at the bedside, and then married to those studies that I started to ask myself, maybe this is a material that I need to consider. Looking at that again, the two characteristics that we sort of highlighted, elasticity and pore size, there's significant differences in terms of maybe not so sexy, if we can say it that way. But then you have to start to say if we understand our knowledge in terms of mesh footprint, so to speak, that this is a less dense, each fiber is thinner, each fiber is, the diameter is actually smaller. So it is a less of a footprint, so the thinnest one on the market. So as we put these materials together, what does a sling look like? So it's about the width of your finger and about seven and a half centimeters long and has two polypropylene arms to it with anchors. So let's go through each part of it, along with the introducer, which is very different than some of the other trans-obturator approaches. This is not a two-dimensional, it's a very single dimension, it has a helix that's about 180 degrees. And the shaft of the introducer is relatively small compared to other introducers. I think this is important when you are learning to do the procedure and sort of the muscle memory for those of you who do trans-obturators might have to unlearn so that you can do this properly. So I wanna go through this video real quick. So we'll first talk about the introducer and then we'll move on to the other components of the sling. And I think we're doing okay on time. So this introducer, again, was purposely designed in order to deliver the anchor into the obturator membrane. This is a very different delivery system, not into the obturator internets, it needs to go into the membrane. And this introducer needs to be parallel to the ischiopubic rami. So when you're placing it, we don't recommend any turning or twisting, it is really a push into the obturator membrane itself. And everyone in the room will know it. The beauty of the helix of this introducer is that it is made just to kind of curl around the obturator rami and not migrate out laterally. So you stay out of the space that actually could injure obturator neurovascular bundle. Okay, I am going to continue because again, I would like us to stay on time. On the next slide, the different component is that the anchor is more of an arrowhead sort of shape to it, for lack of a better description. And part of this is so that those anchors can lay on the obturator membrane and have secure placement. And in this, we want their pullout force to be fairly strong to sustain any kind of activity like a cough, a laugh or a squat. So the one side is a static anchor versus the second side, which is a dynamic anchor. And that's really important. And why the FDA required the first IDE to say, because this is a bi-directional adjustable sling. In studies, we know that the ability for this anchor to maintain its placement is well above that which normal humans would be able to generate. So it's about four times as much if from a cough or any kind of other stress event. So this is an important aspect that you can be pretty sure. And this is an area that is somewhat protected. So we know that once it's in its proper position, it's gonna stay where we want it to be. And I think that's a key aspect of it. I am actually going to skip the anchor video because again, I wanna get to the data. Okay, let's talk a little bit about this pathway to market. And I hope you are putting questions in the Q&A. Looking forward to answering them as we are down to about 26 minutes for me to finish up the rest of the presentation. So why did Coloplast do an investigator's device exemption? Because the FDA required it. And there were a couple of reasons. One, we realized that about 2006 to 2010, the literature was really dominated in terms of single incision slings by TBT Secure. The second was that this adjustable sling was different than what had been cleared initially through the 510K process. And so the IDE required naive physicians, which is very similar to the RCT that we might be able to talk about tonight to actually place this link in a population of patients and observe several. And so I'm gonna go over some of the characteristics of that IDE. After the IDE was completed after 24 months, the FDA did clear the ALTUS link. However, globally, they issued in 2013, the FDA 522 for all slings. And so many of the other companies started to leave the market and left really just two or three in terms of being able to offer this type or a single incision sling to our patients. So tonight we're gonna take our time to go through the data with regard to the 522 as well as the IDE. So I was not before I started doing some of these talks familiar with IDEs in that really they weren't necessarily asked for in other institutions or other companies. So Holoplast is really the only one with a free market IDE, has to be a human study and each one of the investigators were basically naive. The characteristics of these patients were relatively young but normal size with a predominance of stress incontinence and about a third or 40% with mixed incontinence. And this was across the United States and Canada at 17 different sites. What's different about how this was designed is not just doing a single cough stress test and a one hour pad test. There was a little more robustness to this actual design in that there were six cough stress tests, three in the lipotomy position and three standing which is different. And instead of just doing a one hour pad test a 24 hour pad test was performed. In terms of outcomes, this showed very strong data that the 24 hour pad test was very high in terms of 90% of patients had a 24 hour pad weight that was decreased by 50% and almost 88% of our patients or the patients had a negative cough stress test. In addition to that, the subjective measures that were evaluated were the IIQ7 to really look at the effect on activities of daily living, the degree of bother through the UDI and then the impression by the patient themselves. And you'll see there was a significant decrease in the scores with the patients being able to do more activities of daily living, having less bother and being extremely satisfied by this. So with this, we were able to move forward with the FDA clearance. Now you probably will see on this slide some other highlighted items. I think right here in the middle, the mesh extrusion rate was approximately 3.5%. I think that's important if you are learning how to do this that as a naive user, you should anticipate perhaps a higher level of mesh extrusion than what you may experience with your retropubic or your trans-obturator. This was, I think, because all of these investigators were relatively naive. In addition, there were non-pelvic pain or hip pain, which I think had to do a lot with how the patients were positioned. But there were no new or procedurally related complications at the 12 or 24 month mark. Okay, we're gonna move forward to the 522 data. So this was a really interesting study design. And if you've ever had an opportunity to talk to any of the investigators, Dr. Erickson is very passionate about how this was sort of come about. It was meant to be non-randomized because they really wanted it to be generalizable to all users. So in lieu of making this a randomized control trial, Altus was compared to whatever you were using on your own, whether that was a full-length retropubic or full-length trans-obturator. And so across 23 different sites with 32 physicians, about 350 women, 355 women underwent these procedures. And so let's go over and look at that data over the last three years. So this was, again, relatively young population of patients, about 56 in the Altus group and about 53 and maybe a little younger in the, but not statistically significant. And then if you look at the population of distribution, there was more patients in the Altus group with straight stress incontinence, but more with mixed incontinence in the comparison group. Surprisingly, there were more patients in the Altus group with ISD, which I think was relatively different because most of us would tend to choose a retropubic for our ISD patients. Similar outcome measures were captured, again, the ones we covered in the IDE, so I'm not gonna belabor the point. But again, we want to really identify that these are safe procedures and they are highly effective and that patients find them satisfying. So let's look at that data. So I'd like to start with a serious adverse events through 36 months, and I wanna highlight, again, first, mesh exposure. And you'll see, as this group of providers have become more mature in their learning curve for using this procedure, the rate of mesh exposure diminished significantly. The rate of other serious events was also significantly lower. So this is a really helpful part because as you look at the transition from a naive user to a mature user, you're starting to see outcomes that are much more acceptable to both us and to our patients. Now, if you look at how many of those patients had to go back to the operating room or have some sort of revision, it was very low in the ALTIS group. So, so far, we can say that we have very similar rates of serious adverse outcomes in this population. What about non-serious? Also similar in both the ALTIS group and the comparison group in terms of retention, recurrent urinary tract infections, or recurrent incontinence, excuse me, and then voiding dysfunction. The thing, the highlights here that I wanna pay attention to are pelvic pain, which many of these patients, in terms of groin pain, it was similar in both groups. There was not a significant difference in de novo dyspareunia, which has been one of the concerns for a lot of our surgeons in terms of sexual function. And I think there's gonna be more and more data published around this. So we'll pay attention to that. And then finally, talking about the effectiveness. So we've covered safety. How effective is this? And if you look at the three-year data, it is, again, comparable to what we saw in the comparative group, when you say, how similar is ALTIS, or the single incision adjustable sling, to either a TOT or a retropubic? And it's all about 80%, even at three years. So how I counsel my patients is that I said, I feel fairly confident this is tracking along with the data that is similar for retropubics as our gold standard. So again, just to sort of emphasize the points, not only was the reduction in pad weight significant for both groups, it was also seen in terms of how many patients walked around with a dry pad and was similar for both groups. So we've got a diminished amount of urinary leakage, either with stress or urge, because it's mixed in some of the group, as well as patients, a large number of patients having a dry pad. Patients' impression was also the same, in terms of, and this doesn't go up to 36 months, I believe that data will be published later on, and that manuscript should be coming out later this year, I hope, but highly, highly satisfactory with patients, in terms of their personal subjective viewpoint of what the outcome was, in terms of very much better or better, and then the IAQ as well as the UD6. Okay, let's talk more, we've talked technical a little bit, let's talk about why, what patients are we using as index patients, and how do you actually implant this? I tended to use this, and my index patient was very similar to what was presented at SGS, I wasn't there, but I did get an opportunity to review some of the data, that I chose as an index patient, my copolysis patients, that was for me, the lowest risk and the potential high yield for being able to see how well this sling was performing in my patients. But I wanted to kind of go over a couple key points to say exactly how does this sling differ from your trans-opterator? So, if you've ever used some more elastic sling, you're gonna have a little tiny cute incision in the vagina, this is different, you're gonna need to use a significant amount of hydrodissection, most of us use somewhere between 10 and 20 cc's of anesthetic solution, and we make a fairly large incision, it's like one and a half to two centimeters, you as a surgeon need to be able to palpate the medial aspect of the ischiopubic brain line, because that's your target. And I usually end up marking the superior opterator, a superior medial opterator for Raymond, just for reference, so I'll have sort of a visual cue where I'm going. Next, and you'll see on this image on the left-hand side, the anchor is actually on the trocar, and you start with a static non-tensioning anchor. And so this is gonna get deployed first, through that incision, the key is, once you get that anchor into its right location, near its target, you need to change the direction of that shaft of the trocar to be parallel key parallel to the ischiopubic brain line. Because again, this is not twisted into its position, this is pushed, or we call it a cephalad drift, and you'll see that if you ever come to the lab. So to emphasize again, you will push or pass, press, and then avoid that twisting motion in order to deploy the static anchor, and keep in, I usually keep that anchor or trocar in place, and then go to the other side. Little different than if you've ever tried to place both of your retropubics, they end up looking like nunchucks, or if you've ever passed both of your TOT arms, it's a little too tight to do this. Because of the footprint of the introducer, you're able to do it fairly easily, even if in a patient that has a fairly narrow angle. I love this thing from a couple standpoint. One, when you're in the right spot, there's not only a tactile feedback that you're in the right space, you actually hear. And that feedback actually happens when those legs are in the right position, and when your anchor is in the right position, or I should say the trocar is in the right position. So you will feel a pop, and you will hear a pop, and so will everyone else in the room as it deploys through the obturator membrane. The next step is to rotate the trocar so that you can see the gray part of that introducer. Again, something you would see in the lab. Key next step, and the second part, which we're not gonna show the video, but that dynamic anchor has a standard position that when you unwrap it, you will find it. You need to move the anchor so that the memory of that will diminish. And then I generally move it just outside of its original location. If you are too close to the sling, you will not be able to adjust the sling as much as you want to. And especially in someone who has a very narrow pubic arch. In terms of tensioning, you have to be sure that this lies flat. Key principles for this is making sure that our dissection is not conical. It has to be a very wide dissection all the way out to the obturator membrane, or I should say the obturator internus. So if there's any cording or folding or curving of it, you need to adjust your dissection in order to make this thing lie flat. It has to lie flat. And as you are adjusting the tension by pulling on that blue polypropylene suture, you are just watching the tissue touch or kiss the sling. It is not meant to have a gap in it, very dissimilar from your elastic sling. Now, if you were too tight, you can always use an instrument to loosen it up. And that's the beauty is that you can go back and forth, in particular, if a patient is able to either cough or you want to perform it per day. So again, this is worth a screenshot. Key steps or principles are patients have to be in sort of a mid-lithotomy position. The dissection is very wide to accommodate your finger so that it will lay flat. You follow each step of the technique that we've described in order to keep those introducer arms parallel to the rami. And you want to be careful about over-rotation past the obturator membrane and not getting into the obturator membrane. Again, things that you can cover in a lab, which I really, really hope you will be able to attend. All the patients are recommended to have cystoscopy. When you cut the suture, I usually leave a little tail just in case you ever had to go back and find it and you don't want to have to replace the sling and it's total, you can hold onto it. And a little different than if you ever going back in an elastic sling and had to adjust it, you know you're not adjusting, you're stretching or deforming that sling. With this, if you get in within the first couple of weeks, if you had to, you can actually adjust the sling. And then finally closing the incision to make sure it's completely closed because it is a two centimeter incision. We usually send our patients home the same day if we're only doing a sling. There are several people that are doing this either in a surgery center setting or an office setting under local anesthesia. Patients do very well in terms of pain with limited need for narcotic. Patients can go back to many of their normal activities. I'm still very conservative in what I ask patients to because they don't trust them. What I've heard and seen from patients and what I've heard from colleagues who have done this far longer than I is that the pain compared to a retropubic sling is very different. And I can't often emphasize how much I've seen that, particularly if I'm doing it in conjunction with other procedures. Okay, I have made it very close to time. It looks like I have about eight minutes. I would love to open this up for discussion. I see several questions and I would ask Shelly to help me with some of these. So, let us, okay, what about anchor pain? How would you, how would you approach retrieval of painful anchors? So, generally speaking, if you deploy this into the obturator membrane, you are not going to have anchor pain. So, my concern would be that it perhaps is not deep enough, that it may have only penetrated the obturator internets. I think if you actually had to try to retrieve it, you have some difficulty, but if it was, again, not fully deployed, you may be able to tease it out. The key is you would want to get into that, you'd want to get in fairly quickly, because once this, once you get to about three weeks, it really is much more challenge to try to revise the mesh in general, meaning to try to take the entire mesh out. Okay, next question I see is, if the revision or excision of the altus is required, what is your experience with recurrent incontinence? Yeah, so I have had one, two, three revisions. The first was a patient who had COVID and just basically coughed the heck out of it and loosened it up to the point where I tried to go back and tighten it up and it just didn't work. So, I ended up doing a traditional retropubic in because of her risk factor and my concern for underlying ISD. The second patient who was also experiencing significant constipation was valsalva. I just elected once I opened it up, it looked fairly normal, but I was concerned about just her inability to void completely and that was within that two-week period, I replaced the sling, I replaced it with a second altus. The third, I went in and a patient had voiding dysfunction, but she also had other comorbidities. She was on several anticholinergic drugs or had anticholinergic effect. She had lower back pain and I think had some underlying radiculopathy. So, once I got in, I did not see that the sling was too tight and I had also done a concurrent Botox on this patient. So, I elected to keep the sling in its same position and just basically do self-cath. So, essentially, I have not taken out a sling and just left the patient without some other form of an anti-incontinence repair. I think if you're in fairly quick, you can replace the sling easily, it's just much more challenging if you wait and have to do a significant dissection. Okay, the next question I see, and Shelley, you can keep me on track if I am repetitious, would I do a single incision sling with ISD? You would have asked, if you would have asked me this maybe two years ago or three years ago, I would have said no. But sometimes you do things and you don't mean to do them. So, I have actually had experience where I've done ISD patient and had really good results. And as I talked to more of my colleagues, they don't distinguish as much anymore. I think part of it, and even though that this thing has a very typical trajectory, like a trans-obturator, I think primarily because of the way you do that dissection, it's a lot more significant in its full thickness, you get a lot more surface area attached to that to the urethra and you get a lot more support. So, I don't, I personally don't see a lot of recurrent incontinence with my ISD patients when I've done them. Usually, I would choose a retropubic. And if you look at the data, there were more ISD patients in the 522 data. So, I think we're going to start to see some deviation of practice patterns based on this. Okay. Next question was, how does ALTIS compare to other minisinks, specifically the SOLIX Blue? I cannot speak to the SOLIX Blue because I have not utilized it. But I do believe part of the difference is just the limitations in terms of adjustability. And again, it is the type of material I think also, again, I am here because I believe in the mesh. And I believe that that less elastic mesh is really important as a suburethral support. Okay. What was the problem identified? Oh, good. In the naive implanters. That's a really good question. That had a 3.5% rate or higher. Yes. So, each one of those was in the mesh extrusion was in the same site. And it was a technique issue. And when they corrected it, that person who was having the mesh extrusions didn't had no longer. So, I think it was a primarily a technique issue. And so, many of us are used to retributes and doing sort of a split thickness graft or split thickness vaginal dissection. This is really much more of a full thickness. And so, if you haven't had the benefit of doing transvaginal mesh, it may be a little bit intimidating because you are going on a lot deeper, particularly towards the fornices where some of those little buttonholes or extrusions can occur. All right. Have you ever used Solix? I've used Mini-Arc, but I've never used Solix. For those people who have used it, you know, I'm not going to try to compare apples to apples or apples to oranges. I don't know other than the significant difference in the mesh properties. So, I think I would table that to someone else who has a lot more experience with Solix, if you don't mind. And another question was next step in a case for a failed SIS. Great, great question. So, it depends on who you talk to. I know some of my colleagues are doing a readjustment or they're going back and doing another single incision sling. I would tend to use a retropubic and or depending on the degree of failure. If I found a patient who was having minor leakage but still bothersome, I may actually offer bulking to them as opposed to doing a redo or another sling. Okay, next question. Does the size of the patient matter in regards to the sling choice? Specifically, someone who has elevated BMI. If you look at both the IDE and the 522, those patients were BMI approximately 30, a little bit higher. I personally think with the anchor-based system in the obturator membrane, you may actually have better sort of support and stability because there's a lot less movement. That's my timer just telling me I need to make sure I'm cognizant of time, but we're actually doing really well. So, and thank you so much for all these questions. They're actually really good. So, in our obese patients, I would tend to use an ultus. Now, the challenge you're going to run into is, as I've emphasized, that arm or the introducer needs to be parallel to the ischiopubic rami. The problem is, is that that's where some of the girth is and you may have a problem with trying to get that trocar with soft tissue interference as opposed to actually making it around the rami itself. But if you can get it into that obturator membrane, I've not seen, and we have, like everyone else, a relatively large, because I work in a parallel to a bariatric practice, so I get a lot of bariatric patients referred to me, and so I've not seen an increase in failures. Okay, next question was, what does the long-term data tell us? So, we're now up to three years, and I think from the summary, we have a few things. Number one, that they're very similar in terms of retropubic, as well as trans-obturator compared to the single ascended and slain. Now, Catherine Matthews presented, and I do believe that there's going to be an updated presentation by Dr. Matthews and Dr. Cole coming up next week, if I'm not mistaken, to talk more about their randomized control trial when they compared altus to gold standard retropubic slain. The key for us is that that was a population that was selected differently. These were in the 522, and the IDE was really just stress incontinence patients with no other concomitant surgeries. In that randomized control trial, these are patients that actually had fairly significant prolapse along with incontinence. Okay, this was a very thorough... I'm reading this. I apologize. In all fairness and full transparency, the other SAS are currently on the market have the same long-term, yes, Boston Scientific Caldera. That's worth mentioning to the audience who think, I agree. I probably should have emphasized this. I was really trying to get through the data, but I will tell you, I'm not here to tell you this is the only thing you should ever use. I am happy that we have options for our patients. For many of you, and I'm not sure of the audience because we haven't polled you, but for me, when I first started and we really were only offering laparoscopic birch versus an autologous slain, it was very different in terms of outcomes. Then we had much more in terms of offering over the 2000, basically year 2000 up until 2010 or 2012. I'm here because I really want to maintain our ability to do these types of surgeries for our patients. I don't think that I'm gonna bash one sling over the other. If all I had was a Boston Scientific Solis or all I had was a Caldera, I wouldn't bash it. I think the key is that the COLA class has really done a good job of trying to be respectful of women's health by making sure they do the studies that is required by the FDA, along with encouraging other providers to also do those studies as well. I do agree that ALTIS is definitely adjustable. I think for those of you who had experience with the Mini-Arc when it was available, that was sort of the jump, the ability to try to adjust and do more sort of fine tuning of the sling. I think that aspect of it has made it much more sort of, okay, maybe I need to reconsider this as a possibility. Okay, we have a few more questions and about 10 more minutes. I'm going to keep taking them. More elasticity in other slings at baseline compared to ALTIS, but their integrity and subunits of stabilization once the tissue and growth takes place is the same. Can you speak to that? Let me try to dissect the question because I'm not sure I understand it. More elasticity in other slings at baseline compared to ALTIS. Yes, that is correct, but their integrity, the integrity of suburethral stabilization once tissue and growth. Okay, I think I understand the question, meaning that once you have tissue and growth of an elastic sling, you will probably have similar, I think what you're saying, stabilization. I don't necessarily doubt that in terms of having something that isn't as elastic because of tissue and growth. My sort of like scratch my head when I began making that jump to the Coloplast product was more deformation in that I really started thinking more, at least I tried like a scientist, in that you want a surface area in the mid urethra that is consistent and that's that one centimeter. When I had gone back on my retropubics, that really shouldn't have had any voiding dysfunction. I found a lot of times, yes, it was stable, but it was also much thinner than that one centimeter where even if it was heat sealed, the tanged edges. So I do believe, I do believe that there is a difference in that aspect of it and there's more stability from the standpoint of maintaining a specific surface area, not just the elasticity. So thank you for that question. Okay, there was another question about what percentage of my slings are now SIS. I am migrating. I started off probably 50-50, I would say three years ago and I would say now probably in all transparency about 90% are altered since I've gotten more comfortable using them in cases where I did not use them before. Number one, I was not using them in my sacral copepaxis because of the, sometimes the anterior wall was made the dissection a lot more complicated and so I found it more challenging to actually deploy a more trans-opterator approach and that actually modified as I, you know, also adjusted how I did my adjustment for sacral copepaxis. Okay, a comment on the SIMS trial finding significantly higher dyspareunia, yes, in the SIS compared to the transurethral or the retropubic. So I believe part of this is again due to placement as well as dissection and I have to go back and look at this actual SIMS trial to say what in terms of baseline versus de novo dyspareunia, but I think it was a fairly high percentage in that SIMS trial, but if we look at a randomized controlled trial that's coming up, which I'm really curious as to what was their rate compared to the 522 data, that's really going to tell us a little more about is it more learning curve related, is it more, is it more, the anchors is where they're going in and there's tenderness there, so I think there are a lot of factors that we still need to explore. Okay, so there was a comment and I will read it just for transparency. Thanks for the presentation, disappointed that it was basically a promotional presentation and didn't include data from the single incision slings as a group. The data on SIS as a whole is very good, all presentations need balance, next time be sure to include data from other manufacturers. Thank you for that and again, this was sponsored, so I agree that it could have been more broad if it would have been me presenting, I would have included several other studies, so thank you. All right, and then the last comment, and I've been an advocate of SIS since its introduction in the market in 2008, your early adopter, and use it for all index patients with urethral hypermobility. I've experienced with Miniarc, the Solix, the Coloplast, and Dasara, they are all adjustable, there's a learning curve to understanding for them all, and I think as you become more mature in your practice and you have broader experience, you do start to see those similarities. I think in the hands of a novice user, it certainly is helpful to have something that you can use as more of a predictable way to teach how to actually place this as opposed to nuance because you have more experience. Any other questions?

Dr. Walton

Colpolast Altus single incision sling

IDE study

522 comparison study

safety and effectiveness

patient satisfaction

revision procedures

long-term outcomes

urethral hypermobility