Novel surgical stapler, followup



thank you very much doctor sharks well you don't need to see that it's no hello okay so the market for this device is big estimated about nine hundred thousand bowel resections for 2019 via the US markets and laparoscopic devices millenium research group about 65% laparoscopic in 2016 I think that includes robotics is included in that with an estimated at ten percent growth rate compound annual growth rate the number is large estimated for next year at about 1.3 million or so and with a 1.2 billion dollar potential market so what we're doing has the potential to be something very very good and most of you know that there are multiple publications showing that advantages to an intricate Portland a stenosis versus extracorporeal and both colorectal and gastrointestinal surgery with the two major things being a decreased surgical site infection rate and a decreased hernia rate and that occurs because when you do an intrical portland asked the most is you can make your incision in the Pfannenstiel way or if you happen to be a notes person which i am not then you can honestly take it through an organ you don't have an incision so that's also will dramatically decrease incisional ernie rates in surgical site infection and the rest of it is important as well but that's not the real driver in my humble opinion even with that though so about 90% of all the ileal college right colleagues to transverse and or left hemicolectomy procedures are done extracorporeal now even in the face of known data to show why is that so I I'm not sure I know 100 percent but there is a perceived difficulty of doing this in a stenosis because of suturing the alignment putting the bound the staple ends worrying about spillage things like that doing an intrical portal anastomosis and those are probably the the reasons and the truth is is that and when most people do in extracorporeal a samosas which I have done 500 of them before I switched to an intrical and asked to Moses myself you don't really know the real advantage of an intricate Portland – you do it because I could not believe that an extra Kippur that any that could be anything better than an extra controlling asks the Moses because I was trained in open surgery I know what open surgery is like and extracorporeal was fantastic compared to that and it is but it's not as good as an intricate Oriole for sure until you try it so last year we presented a very novel in tirana me closure device which I'm sure dr. de Chappell remembers very well I don't think you remember because you weren't here too bad you weren't here and this device is designed to make these perceived complicated tasks very easy reliable and safe to do without suturing and I'm trying oh there I don't know how I run the video and of course I don't see it I don't see the video why don't I see the video should be there's a video of a novel state can you run us some back there click on there is a video that's embedded there it worked in when a small intestine has already been microscopically resected oh yeah it's going side to side functional end in a so peristaltic anastomosis it's been constructed in standard fashion using a 60 millimeter Medtronic stapler the device seen it's gonna right now it's got about 60 millimeter joy a stapler three rows of staples have been removed and in their place is a prong to rotational grasper designed to capture a common and errata me opening we're moving in three rows of staples in essence converts to GI a to a TA stapler here you can see the prongs being rotated from their original position a mechanism when the handle brings the prongs closer together prior to its insertion in the common opening the common opening is identified we have found that it is easier to insert the proximal prong first into the common opening the design of the prong itself keeps the bowel captured while the distal common opening is identified you can see that even though there is manipulation about the prong stays in place the distal prong is inserted into the common opening and the same mechanism on the handle pushes the distal prong out so that the common opening now forms a straight line this is important because the straight line ensures that the posterior aspect of the bowel is captured it measures 2.5 centimeters the prongs are then rotated back into its original position this also makes sure makes sure that the poster wall the common opening has been captured the blade is activated in standard gif fashion firing the staples and severing the portion of the intestinal wall to be removed no extra intestinal wall is removed with this device survival studies have demonstrated an intact anastomosis without stricture or leakage we're gonna move to the next slide real quick I'm trying so that was a 15 millimeter device it's now a 12 that's an improvement from last year I've been told that maybe we can get it down even smaller to that to maybe eight we have survival studies which show and intact anastomosis we know it doesn't leak it works fine there was one adhesion in in this group minor adhesion it's compatible with compatible with a robotic platform which means that the prong activation and the rotation and all the approximation are done with wires can't say exactly how it's done because there's some patent stuff in there but the wires can be connected to a proximal end driving the box which can then engage to a robotic platform its concept of what we're really talking about in terms of robotics there's an add-on option I won't get into that and the plan is to finish real quickly is to secure some more funding to move ahead with the robotic platform capability go start validation very very shortly with a take about six months to do that and apply for FDA approval in first human trials thank you very much [Applause] you

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