Thank you, Matt, it's an honor and kind of intimidating to be up here with this group of people. So this is my, it's actually an invention, the relationships are germane, I got royalties from Smith and Nephew who markets this currently, so, thank you, but prior to my invention, this was the extent of suture passers on the market. All we had were these rigid devices to shuttle a stitch, this was the only thing available, my idea started in 1999, it's been through five patents, three companies with mergers and acquisitions, and this is where it is now. So it's now marketed as a first pass, it's a disposable, comes in two sizes, self-capture and non-capture, can pass tape, can pass suture, and this is used quite frequently. You heard some other numbers today of thousands of patients, so this is over 100,000 patients per year, the uses, and it's now called the first pass. So it was the first of its kind with a nitinol needle, with a variable angle, and with the self-capture, so a lot of firsts that have, I think, transformed suture passing. So what are the benefits? This is a round, pre-curved needle that's nitinol, when you withdraw it back into the tube it straightens out, when it goes out to the end of the tube it always goes back to the same shape. This allows it to penetrate the tissue at a perpendicular angle, which is more advantageous than at a sloped angle. Other passers are flat needles that deflect off a bumper and so enter at an angle, and may be a little less predictable, especially within stiff tissue or bone. And the other thing that's nice, this is most commonly used in the shoulder for rotator cuff and labrum, with the two different sizes, as you can see there, the self-capture trap door really holds suture securely, even if you have just a wisp of suture through the trap door that you see there. But the other thing, this round needle is very, very sturdy, it's much more resistant to breakage. Here's one example from 2016 with the breakage data reported to the FDA, zero breaks with the first pass. You can see other devices, the rate of needle breakage, those of you who use those other devices have probably often encountered needle breakage, that's just basically a non-issue. So the number of passes is not limited per case. You can pass this over and over and over, the needle does not fatigue. So it's very versatile. So here's meniscus root repair, you heard Aaron talk about this. The advantage of this perpendicular access is you really know where that stitch is going to exit, and you can get a mattress suture. The weak link in a root repair is the tissue, it's not the suture. So you can get a mattress suture, you can do rip stops, you can do any configuration you want. You can also do a luggage tag as you see here, but a luggage tag, and we offer a kit that's for this, so you can drill parallel tunnels, but a luggage tag does not increase your strength of your repair, that's just doubling your suture strength, but again, that's not the weak link. So the round needle can also bend left and right, that's unique with a round needle, so you can get angled passers, and that makes it versatile for something like a meniscus radial tear, so we've published on this as well. Here you see a left angled passer that we're using. This is at the junction of the anterior horn and the body, with a deep radial tear that goes all the way across, and here's angled the other direction, then you can flip it upside down and get this figure of eight configuration for the sutures, which gives you much better coaptation of the repair. If you use a box stitch, you tend to get puckering of the tear, which is going to extrude the meniscus. This you get much more side to side compression, then you can shuttle the stitches out and tie them on the periphery. So this is very versatile, so it's most commonly used in the shoulder, but I just showed you the root, just showed you the radial tear, and because of that round needle versatility can be used for other things, so it can be also your suture retriever, not just a suture advancer. You can use it coming top down to deflect off a bumper on the distal end to cause more curve to pick up the suture. You can also have it bend sideways to pick up the suture, you can even have it twist. If you hit threads on the bottom, it can twist and pick up a suture, so lots of different ways it can be used. So versatility, rotator cuff repair, shoulder labral repair, biceps, meniscus root, radial tears, ramp tears, hip, labral capsular tears, ACL avulsions, very, very versatile, impacted a lot of patients, and certainly very strong, and here you see a bony Bankart, and this is a very healthy bite of labrum with tape, and you're going to see that needle come right through the bone, that sliver of bone, and right through this big bite of tissue, so you can see it's a robust passer. So thank you for the opportunity. David, great, thank you. Good job. Questions? Dr. Miller. As partners allowed to ask each other questions? All the time. Chronology of development, who developed what first? So there were no other suture passers on the market when I came up with this idea. This was the very first one with advancing what we think of as suture passers now. Everybody in the room uses suture passers, this is the very first idea of its type. I did not think of a flat needle deflecting off a bumper, so it allowed Rube for that to develop. I wish I had, I'd be retired. I wish you had. Other questions? How often, do you have any data on how often this is used outside the knee? I don't have that data, but just the gross sales data over 100,000 a year, year on year, so quite a lot of patient impact. All right, we're on to our last presenter.

suture passer

first pass

disposable device

shoulder surgeries

orthopedic surgeries