The Minimally Invasive Valve Surgery Symposium is designed to provide an understanding of the various minimally invasive techniques used for treating the aortic and mitral valve, utilizing the On - X heart valve as the platform for valve implantation. The symposium will cover in detail the various approaches to minimally invasive techniques, with particular focus on the hemi - sternotomy, right anterior thoracotomy and video - assisted techniques. Additional areas of focus will include enhanced recovery after surgery (ERAS) protocols, keys to establishing a successful heart team, starting a minimally invasive program and patient outreach and aware ness.
Presenter: John Davis Sr. Vice President of Sales & Marketing Artivion
Please Note: The views expressed during this presentation are the speaker’s own and do not necessarily reflect those of Artivion, the speaker’s employer, organization, committee or other group or individual. Unattributed data, device selection, and procedural guidance is a matter of physician preference are presented on the basis of the individual speaker’s observations and experiences and should be treated accordingly. Federal law restricts the devices discussed herein to sale by or on the order of a physician. Refer to the Instructions for Use and other product insert documentation that accompanies each of these devices for indications, contraindications, warnings, precautions, possible complications, and instructions for use.
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So, um so thanks a lot for being here, everybody. I want to thank the faculty for being here and making your time to, to be here. We really appreciate that very much. The, the last really call it seven years for our company have been very, very interesting and that um we had new leadership come to what was then life and with the the mandate from the board to change the company and to strike out into an aortic focused company and to make the proper aqui acquisitions and the sti chooses in order to make that reality. So we did that next slide. Um And we came up with um the, the name that you see here and we rebranded the company as a result of all of the acquisitions and divestitures that we did over the past seven years. And it became obvious really from feedback from customers that we needed a name change because prior life no longer reflected what we did um globally. Um We're far more global than we used to. We actually have more revenue outside the US than we do inside the US, which was seven years ago, not the case at all. We were basically a US based company selling bio glue uh in human tissue. So now it's, it's completely turned on its head. And as we went into other markets outside the US and said, hi, we would like to talk to you about a, a frozen elephant trunk or a stent graft. Our name is Cry Life. They said we don't get your name. It makes no sense. There's nothing frozen about what you do. So, so we knew that we had to do something uh to change our name and, and that's what we did. And we embarked on the name and uh rebranded as our um which is a combination of what you see here. Aorta uh Aortic innovation and vision. So, next slide, please. I do. Oh, here it is. Ok. Great. That's much better than saying that. Thank you very much. Um So the um the journey is this again, I, as I said, um seven years ago, uh in 2016, we decided that we would embark on uh the first purchase of buying on and in the same time divesting Hero, we acquired Yote, which is our German Stent graft manufacturer. You'll hear a little bit more about their products um in a couple of slides because they are on their way to the U. Um And then we signed an option agreement for another stent Graft company, an Israeli based specialty stent graft company for um Aortic Arch. Um uh treatments. And then finally the Cyrus Medical Company and we got the AM DS uh uh device for type a dissection. And so that was the journey and that's what led us to the rebrand of our. So that's just a really quick uh you know, what happened to cry life and why. And when, so as we look at our mission, we lower left hand corner is simply this, we partner with you to restore the health of patients by delivering innovative technologies of unsurpassed quality. That's pretty simple. And that's what we're about. Uh the products on the right hand side of the page is what I'll draw your attention to particularly the top three. So the AM DS device and the Nexus Device, they're currently uh enrolling in US ID E trials right now. Um And the Neo device uh will have design freeze on the US version of that device soon. And then that will be the next one to hit uh the the clinical pathway and then the next devices will be coming in in subsequent years. And then this is our entire portfolio that you see in the US uh both on the cardiac and vascular side of our Allegras. Um And also the, the, the heart valve solutions and the ancillary products. These are the ones you're familiar with. Uh this is how we're growing very deliberately. You can see that the majority of our growth is happening in Europe and in Asia, we are really growing very quickly. In Asia, we've had a, a wonderful uptick of demand in Asia that was actually on, on, um, kind of un forecasted if you will, but it's really going fast there. So that's where we're gonna be growing. Um And then you'll see that US number, that North America number is gonna pop up really big right at the end of 25. As we bring those stent graph products into the US. This is where we make what we do. Uh In Atlanta, we make bio glue and in Austin, Texas, we make the Ony Valve and hecking and Germany, we make the ST grafts um on when they built that factory 30 some odd years ago. That seemed like a really good idea to put a factory in, on Austin Texas. It's a today, a really bad idea because getting labor for Austin Texas is not easy. It's become a competitive, a very competitive market and it's become a more expensive place to be, but we're there and we're not moving. It's, it's our footprint. And suddenly in the last five years as Austin has become Austin, we've had people all over the company that have developed a keen interest in going to see our factory. It's really amazing. Um uh So we've, we've had to limit our visits to our val factory, which is, which is surprising. Um And then our valve solutions for life and, and really just looking at the two on the left is what I would draw your attention to. And really, that's the, the valve um with the low inr and also the one thing we sometimes forget about and that's our C valve and the, the data behind that and 87 87% freedom from intervention at 10 years versus standard tissue. That's a big deal. And uh and it's accounts for the popularity of the valve and the fact that we're having a difficulty with supply right now. Um and then um the proact uh series if you will and what that's done to redefine the same valve. This is the same valve that was originally produced by jack rows back in the, the, the, the very origin of the, of the product. Um but through clinical trials and, and moving it forward that way with the lower inr indications, um has really, you kept the same valve with advancing indications uh because of the qualities of the valve and the clinical work that was done in that regard. And then finally, I wanted to talk briefly about these devices that you don't know about probably. And that is the first device that's going to be in the US. They're on the left, which is the AM DS device and that's for type a dissection and it's, it's an adjunct with a standard, but it's a much more complete repair and it, it, it also results in remodeling the vast majority of the time. And so this is a device that's not necessarily designed for those centers who currently do frozen elephant trunk. And that are the, the, the the centers that do this all the time. This is really gonna be primarily for those surgeons that do, which are, which are most surgeons, actually the centers that do two or three a year. Um that this is much better than a standard uh ach, but it's not that much more difficult than doing he ach, but it's a much more complete repair. So we think that that's gonna be the target for this. We think other people will probably just, you know, opt for doing a, a complete frozen elephant trunk when it's available. Um So that's that device and then our frozen elephant trunk, the neo is just going crazy in Europe right now. We we literally can't make enough. Um And that is the device where that will be coming to the US after the Nexus device, which is the one you see on the right, that's the endovascular device that is for those uh particular uh kind of, I guess arch aneurysms that are just so tricky that you, you don't dare go in with an open repair. And that device is also be will be coming in a dual branch device uh within about a year and that trial is going on in the US right now called the Triumph study. So in summary, um we try to surround the cardiac surgeon. Uh We try to make it very, very, um deliberate and clear to you that you are our customer. Uh We don't dabble in, uh, catering to cardiologists. We don't dabble in anybody else. You are it and we are very proud to have you as our focus.