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Dr. Chapa’s OBGYN Clinical Pearls
A Mechanic’s Vision: The OdonAssist™ Device (Not Ready for US Approval)
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Well, it seems fictitious, but it's not. It is absolutely true. And it seems like it's some weird Hollywood script, but again, it is not. It's a real case. So what does an auto mechanic, a cork stuck in a bottle, and a baby's vaginal birth have in common? The answer, nothing. Unless you are Jorge Odon. Yep. This auto mechanic was looking at videos and saw this trick of how to get a cork that was trapped inside a wine bottle out without cracking the bottle. And the person in the video used a sleeve filled with air to coax the cork out of the bottle. So of course, as an auto mechanic, because why not? He thought, wow, what a great way to possibly get a child that's trapped in the vagina out of the vagina. So he did what any good auto mechanic would. He went to his kitchen and took one of his child's dolls and made a prototype. Yeah. That actually got picked up and marketed as the Odin assist device. Amazing. Now, we're going to cover a couple of things here because there's a lot of take home messages here. The first is if you have a vision, if you have an idea, go for it. Hey, you never know, there could be the next Choppa Assist device. There isn't. But all to say, run with it, why not? This thing, this, that Jorge Adon, an auto mechanic came up with in his kitchen is now a marketed thing, not in the United States. So that's the first lesson. If you have a vision, do something about it. Number two, put it to you. Go and take it to somebody and see if they can actually do this in kind of a clinical trial. And that's what they did. So we're gonna talk about the data behind the ODIN assist. And even though. Here it is, guys, spoiler. Even though it is not a FDA approved nor is it anywhere close to being FDA approved, this actually has World Health Organization endorsement. They like love this thing. They're like, oh, this thing is great. And it is in low resource settings where the practitioners may not have the skill or training for a vacuum or for forceps. Let me just be very clear. I don't see this thing taking the place of vacuum or forceps, which are entrenched and, and very well embedded in our practice of obstetrics anytime soon. That's not going to happen. However, for low resource areas where potentially they don't have either the equipment or the training to do that, this potentially is an option. That's why the World Health Organization said, hey, there's something to this here. Let's not just discard this as nothing to see. So they actually do like this. Not only do they like it, but the European Union, the UK has also approved this through the CE mark approval. So we're going to talk about this because even though it's not ready for use in the US this is things going around on social media. And of course once it's social media, you know, boom, it starts blowing up. Actually, one of my OB GYN buddies here in town actually sent me the video. He's like, hey, look at this thing. Because it looks kind of freaky, let's be honest. It is kind of like the cone of shame that, that you put on your pet so they don't scratch their stitches out. It's a little plastic bag that goes over the head of the child in the vagina, then, then gets inflated with an air cuff around the baby's head so that atraumatically it uses a friction free glide as the bag on bag apparatus pulls the baby's head out like the cork was pulled out of the bottle. Now it, it's, it's kind of clumpy, it's, it's kind of awkward. But there is data. But I'm gonna tell you again why there is data and then there isn't data. And I'm gonna explain what that is in a minute. We're gonna talk about the assist Trials, both assist 1 and assist 2, and why it is not. Let me be very clear, it is not gonna be appearing in ACOG's practice bulletin number 219 on operative vaginal birth anytime soon. And the reason is it's a long way from FDA coming clearance because the FDA has a different approval process than the CE mark approval in the United Kingdom, in the uk. All right, so even though it's not approved for use in the us I'm sure someone's going to tell you, hey, look, put this bag around the kid and get the baby's head out. But we're not quite ready yet. So in this episode, we're going to talk about this crazy Argentinian who came up with a great idea and didn't just leave it in his head. He said, hey, let's do something with that. You know those crazy Argentinians. Don't cry for me, Argentina. Oh, boy, do they love their soccer and their Evita. All right, I think I've set it up enough. We'll be right back with the ODIN vaginal Cyst device. We're just trying to fulfill our life calling and our mission. This is Dr. Chapa's OBGYN no Spin podcast. Argentina is a beautiful place, great food, wonderful people, and I love their little Argentinian guitar. It's almost very different than a Spanish guitar, but man, Argentinian guitar music, they're just so calming. It's awesome. So this Argentinian auto mechanic figured this thing out. Hey, let's put a bag within a bag, put an air cup within it that gives out a set amount of air, and let's suck the kid out of there. Out of the vagina like a cork in a bottle. Crazy. And what's even crazier is that, yeah, this thing got like, you know, patented and manufactured. So good for Jorge Odon. It is Odon, or in the US it's the Odin Vaginal Assist Device. And again, just to be clear, while not approved for use in the U.S. maybe, hey, I'll do an episode when it gets approved. But we are not close to that at all. I mean, remember, it's gotta go through phases. And because this is a brand new mechanism of action, it doesn't use focused suction like a vacuum or traction by forcep hands or blades. It'd have to go through a denuvo pathway, which was a different regulatory issue. All right, so this does have some challenges for use in the US Although as the World Health Organization gave it, it's kind of its stamp of, you know, creative ingenuity and, you know, new product on the horizon for low resource settings. I think we should be aware of this thing as to what it is as an inflatable bag to take the child out, to extract the child's head out. And then once the Head is out, the bag just kind of falls off, you know, kind of limp. It's remarkable. So here's how this story goes, right? Here's the account from Jorge Odon himself. He Woke up around 4am he saw this little wine trick because, you know, why wouldn't you look at TikTok or whatever your social media things are at 4 in the morning. And there was a guy who was taking out a cork from a bottle and using this bag that he inflated with air to kind of pull it out in one piece, of course, out of the bottle. So then he used a large glass jar to simulate the vaginal birth canal. He took his daughter's doll as the baby trapped in the jar, and then he made a sleeve with a air cuff around it to kind of drag the child out of the, of the jar. And lo and behold, it worked. So yeah, that became the prototype. And then we jump from that. That was around 2005 ish, 2006. Then we go to the first peer review publication this in 2013. So this is, this is not necessarily new in the sense that, you know, it just came out, you know, yesterday. This has been around for over a decade. But what is new is that now it's being kind of promoted, so to speak, and marketed. And even though it's again, not approved in the US on social media. All right, but this was in the December 2013 International Journal of Gynecology and Obstetrics, who showed an initial feasibility study in a cohort of 30 Argentinian women. Now think about that. That's some brave women. All right, so they got this contraption. It's this basically this big applicator that goes into the vagina, goes around the baby's head, leaves this bag within bag apparatus, goes completely around the baby's head. It inflates a cuff of air and then around the baby's head to provide kind of a grip. And then you just pull the bag out. I mean, just literally just pulling the bag out and the head is, in theory, would come out. 30 Argentinian women said, yeah, hey, let's do that. That is some brave women. Well, out of this very small initial Argentinian pilot, 29 of 30 attempts were successful. So this is why people got excited. They're like, woohoo. That's 96.7% success rate with an N of 30. This is why the numbers matter, guys. All right, so this is a good lesson in statistics. The smaller number that you do if you're successful is great, but that doesn't mean real World issues. This was an N of 30 for which it was successful in 29. That's a 96% success rate. Actually, 96.7. We're not going to end there. But that's what people got excited about this. And as a safety profile, they're like, hey, there was no real severe maternal or fetal issues here, so 96.7% sounds great. Yeah. But then came a larger study. Remember that was in 2013. Five years later in BJOG in 2018, this was the World Health Organization multicenter feasibility study. Notice now the WHO comes in and nothing about their perspective. They're dealing with world clinics and world environments. All right? We're talking about remote parts where they don't have a vacuum and or don't have forceps or don't have people trained in that. So the WHO is like, hey, rather than getting babies stuck in the vagina and dying, we'll take anything. So let's do this as a trial. So the WHO got involved and in bjog, that was published as their feasibility study. Now in this, success rate was still pretty darn high. Okay, let me tell you, success rate was still pretty darn high. It was 71% who had successful delivery. 71%, but you notice that's already a drop from the 96%. This was in 35 of 49 attempts. Again, small numbers here, but we already go in the whole feasibility study down from 96 to 71%. Now, in this study, they did have some first and second degree vaginal tears. There was a minor cervical laceration also reported, and that occurred in about 59% of women. Not the cervical lack, but the first or second degree. Some kind of genital tear in 59% of women. But there was no third or fourth degree lacks. And all neonates were born vigorous with favorable six week and one year developmental outcomes. So that is reassuring. But to think that this is completely atraumatic is not necessarily the case because a head is still coming out of the vagina, so it doesn't make it immune to normal vaginal lacks and trauma. All right, so now we're down to about 71%. We're just going to do this quickly because again, I don't want to get too much details into the mechanics of this or the numbers because the numbers are very small and it's not yet FDA approved. I just wanted to give you an idea of what the ODIN assist device is. And I posted a little video on this on Instagram where you kind of see a schematic of what this thing looks like. It literally is a bag around the kids and head. It looks like a. Like the cone of shame. Okay. And then you just pull from that, once the cuff is inflated, the air cuff and the head, you know, in theory, is supposed to come out fine. So now let's leave that and go to 2021. Notice we're walking down the timeline from 2013, 2018 to 2021. This is Hotten et al. This is now in the gray journal. This is the assist device. This is all uk. None of this is us. All right, so in the ajog, this was a cohort of women from Bristol, United Kingdom, and in this case, again, an N of 40. But the successful rate of delivery was 19 of 40. Now we're at 48%, guys. Substantially lower than traditional vacuum or forceps success. The remaining 52% required secondary assistance with either non rotational forceps or an emergency C section. So you see how the numbers now are going? Well, we're not in Argentina anymore. All right, so outside of that one little pilot that showed a 96.7% success, now we're down to a 48% success, statistically and clinically, much lower than vacuum or standard forceps. Okay.
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Now, here's the other issue. As the more that you test this thing, more things comes to light. They did have some device issues, some some technical issues with application. And in that study, it showed a 10% malfunctioning rate from the device. Either the cuff didn't inflate well or it didn't pull right or whatever. That's 10%. That's a lot. All right, so you see now why it's not close to FDA approval. That was in 2021. Then comes assist number two. This is the assist number two trial, also in AJOG, still out of the U.K. again, this is yet another feasibility and safety study. They're trying to get those numbers up, but nonetheless, the device was still successful, just in 66% of cases, which is, you know, not bad, but it's definitely not equal or non inferior to standard operative vaginal techniques that we have at this time. So why is this thing not FDA approved? Well, because we haven't done the right trials. The CE mark approval in the UK is totally different than the US and this is relatively new, guys. Remember it just got UK's approval in spring of 2025. That's just over a year ago. Okay, but, but they have a whole other process. We're much more rigorous. I'm not saying we're better or you know, or anything like that. I'm just saying it's different. But the FDA process is much more rigorous and much more demanding in terms of safety and efficacy. So this has not received 510 clearance. This would likely need de Nouvo classification and it would need to go through formal trials that show non inferiority. And since we don't have any comparative relative data on that and we definitely don't have any randomized trials on this, it is nowhere clear, nowhere clear or close to being FDA approved. But I found this so interesting because a buddy sent me that, that video and he's like, hey, check this thing out. And yeah, it's fascinating. I think it's remarkable. I hope one day it does work. But it would have to be proven to be non inferior to standard vacuum or forceps. Plus the other question is what if the baby's OP that wasn't well studied? We don't know that. What if it's asynclytic? Right now you can use a vacuum at C section for the non engaged fetal head if you have to. If you can't get the head to engage through the hysterotomy, you can do a vacuum. I don't see this thing being used at a C section. So there are a lot of limitations however, because I don't want to seem like I'm poo pooing this and I'm not. I mean, kudos to the vision of Jorge Odon to make this device a reality. I do think this has value in low resource centers who don't have any other option. And it's either this or, you know, the child is in jeopardy and peril. That's a different issue in those centers. I agree with the who. Maybe this thing has some value, but we are not ready for PrimeTime in the US anytime soon. So Argentina, thank you for your great love of soccer, thank you for your wonderful guitar music and for the Adon vaginal assist device, but we are not quite ready for you in the US podcast family. As always, we're thankful for you. We're glad you're part of our podcast community now, Michael. Now that we've done all that, let's take it home. This is Dr. Chapma's OBGYN no Spin podcast.