Selected Podcast
Former Engineer Now Designs for Heart Patients
Sanford Health vascular surgeon Patrick Kelly talks medical innovations.
Featuring:
Learn more about Patrick Kelly, MD
Patrick Kelly, MD
Patrick Kelly, MD, practices vascular surgery, and is a board-certified and fellowship-trained surgeon. He is an active inventor of medical devices, with over two dozen issued or pending patents and several approved, physician-sponsored clinical trials.Learn more about Patrick Kelly, MD
Transcription:
Jacqueline Palfy (Host): Hi. My name is Jacqueline, and I’m here with Sanford Health News. We are talking to Dr. Pat Kelly today about some innovative work that he’s doing. Welcome Pat.
Pat Kelly, MD (Guest): Yeah. Hi. How are you?
Host: I’m pretty good.
Dr. Kelly: Good.
Host: Thanks for coming out today. So, tell me a little bit—you’re a vascular surgeon. Is that the right title?
Dr. Kelly: I am now!
Host: (Laughs) Wow. What did you used to be?
Dr. Kelly: So, in high school, I wanted to be a draftsman, and then I decided I was going to go to college. So, then, I went to college to become an engineer. I really probably wanted to be an architect. Probably I’m more creative than I am analytical, but architects—the hill that architects have to climb is challenging so I decided to be an engineer.
Host: Okay.
Dr. Kelly: It’s much more predictable.
Host: And you’re from South Dakota, is that right?
Dr. Kelly: I grew up in South Dakota, yeah.
Host: Okay. So, you grew up in South Dakota and started a career as an engineer. Tell me what that was like. Was it what you expected?
Dr. Kelly: Well, probably for the first six, eight months, and it really—so when I was in high school, I started working as a draftsman, or at least, a blueprint boy. I ran a lot of blueprints, and then, in college, I worked as a draftsman for an engineering firm in Laramie. That same firm had an office in Brookings. So, I just moved from Laramie to Brookings and started a position as an engineer. Punching numbers, designing bridges—all sounds really cool first few times and then it gets really boring—punching numbers, sitting at a desk all day long.
Host: So, you got a little bit bored with that.
Dr. Kelly: I did.
Host: Is what it sounds like and then what happened?
Dr. Kelly: One day, and I tend to do this, just one day, I just made the decision that I needed to do something different. So, I made that decision, and I decided I would try medical school.
Host: Okay. So, this is what makes you interesting to me is—a lot of people sit there and think, “I need to do something different,” and then they just keep doing whatever they’re doing, but you did not do that. Why medical school?
Dr. Kelly: I don’t even recall.
Host: (Laughs)
Dr. Kelly: I don’t even know anymore. I think it was a challenge. I made that decision—I was going to try to do medical school, and I remember when I went to the university at SDSU and told professors there that I thought I would try to go to medical school, and they’re like, “You’re an engineer. You don’t have any biology. You’re not going to get it in medical school.” I’m like, “I’ll get it. I’ll be fine,” and I did just fine.
Host: And it worked out okay.
Dr. Kelly: It did.
Host: So, you go through medical school, and you graduate and then what happens?
Dr. Kelly: I did a surgical residency. Probably my first few days in residency at the VA, I realized I wanted to be a vascular surgeon.
Host: Okay. Why is that? Did you know you wanted to be a surgeon when you started?
Dr. Kelly: No! I actually—
Host: Okay.
Dr. Kelly: —thought I’d be a pediatrician, and anybody who knows me knows that that is crazy, okay? I’m not patient enough to be a pediatrician—probably could do with the kids, but the parents. It would be awful. It’d be awful.
Host: Well, that’s probably good that you figured out that before you got all the way into that career (Laughs).
Dr. Kelly: I did. I actually figured that out about my first clinical rotation.
Host: Got it. So, you decided to become a vascular surgeon. Why? What was appealing about that?
Dr. Kelly: It was the path of most resistance. It was—at that time, everything was done open. The outcomes were awful. You know, they were difficult operations. It was very technically demanding, but the one thing that was really cool was it was grumpy old men that were really appreciative of what you could do for them.
Host: So, okay. So, part of it was the clientele.
Dr. Kelly: It was totally the clientele. I tell my medical students—you pick your specialty based on the population of people you want to take care of—not the specialty based on procedures because if the procedures don’t become mundane and boring, it means you’re not any good at them.
Host: Oh. Okay. That’s interesting—
Dr. Kelly: Okay?
Host: —because the people are who you’re going to have to deal with over and—
Dr. Kelly: Exactly.
Host: —and over and over.
Dr. Kelly: And that’s—well, and that’s the rewarding part of it. That’s the gratitude. That’s what gives you the reason to get up there and do that miserable operation because you’re going to make that person better, and it’s the type of people—or it’s at least a patient population—you really like dealing with.
Host: Sure. So, grumpy old men is your thing. That’s how—(laughs)
Dr. Kelly: They are not offendable.
Host: (Laughs). That’s probably good. So, tell me how your background as an engineer influences your thinking as a surgeon.
Dr. Kelly: Well, I think as an engineer, you know, an engineer is a degree in problem solving, you know. You’re faced with a problem; you break it into its smaller root problems, and you solve one problem at a time. It’s kind of like The Martian, you know, the show The Martian, you know. One problem at a time, and once you solve one problem, you move to the next problem, and I like that about vascular surgery. Vascular surgery is very much “solve one problem at a time,” and it’s plumbing. It’s really simple.
Host: Um hm.
Dr. Kelly: It’s not scholastically or academically challenging. You’ve got blood flow in. You’ve got blood flow out, and you’ve got to have a pipe in between. It’s not real difficult. It can be technically very challenging. So, you need to know what you’re doing, but it has great opportunities for problem solving.
Host: So, it’s really the same mindset for both kinds of career; I mean that’s—
Dr. Kelly: Or at least I made it that way.
Host: Yeah. (Laughs). You make your own luck in this game, right? That’s what—
Dr. Kelly: To some extent.
Host: Absolutely. So, you have this passion for problem solving—it sounds like. So, that has led to a fair amount of inventions through your work with Sanford, right? How many patents do you have? Do you know off the top of your head?
Dr. Kelly: I don’t. I think it’s over 200 now worldwide.
Host: Which is pretty amazing. What was your first patent in?
Dr. Kelly: Well, the first patent I filed was back in 2008, which never went anywhere because I didn’t understand the process. Since then, I think we first filed a whole bunch of them in 2012.
Host: Okay.
Dr. Kelly: Those were all revolved around stent grafts.
Host: Okay, and this what—a little bit about what we’re talking about today, right?
Dr. Kelly: Um hmm.
Host: Stent grafts.
Dr. Kelly: Yes.
Host: So, tell me, as a regular person here, what is a stent graft?
Dr. Kelly: So, how I like to explain to my patients is a stent graft—I mean, it’s a construct of a metal scaffolding like chicken wire with cloth or some type of impermeable material over the top of it. That’s—
Host: Okay.
Dr. Kelly: —in the kind of the gross simplistic manner. So, you can imagine if I’ve got a pipe and the pipe is bad, either because it has a hole in it, like an aneurysm, or it’s just irregular and it’s clogged. If I can go inside that pipe and put a new pipe inside it, and either re-expand it or have it expand on its own, I re-line the pipe and have it work well, and that’s all a stent graft does, and that’s all a stent does. It’s just relining a pipe. That pipe happens to be our arteries or our veins.
Host: Um hmm. It’s very weird to me to like think about that, right, that you’re building internal scaffolding for veins—so that’s right?
Dr. Kelly: And arteries.
Host: And arteries. Okay. I want to talk—tell me a little bit about this device that you’ve created that recently received fast tracking through the FDA. We’ll get into what that means with the FDA in a minute, but what exactly is this device?
Dr. Kelly: So, the aneurysm that most of us think about—
Host: Define aneurysm.
Dr. Kelly: I will.
Host: Honestly, I think some people don’t know what that is.
Dr. Kelly: Sure.
Host: I tried to tell my kids today what I was doing, and they’re like, “What’s an aneurysm?” and I’m like “Ummm, I’m going to have a better answer at 5”. (Laughs)
Dr. Kelly: So, it’s an abnormal dilation of an artery or vein, but it’s abnormal dilation of a blood vessel. So, you can imagine you have a vessel that’s—let’s say—it’s a half inch diameter. Then, all of a sudden, it expands up to three inches in diameter, okay? You can imagine if that was like a garden hose that expanded three or four times it’s—it’s going to be weak, and it’s going to most likely start leaking at that spot in the garden hose. Well, an aorta’s no different. It’s a pipe that has a fixed diameter, and there’s a segment that may—dilates up, and if it’s a straight segment that doesn’t have any major branches or, any, you know, like the renal arteries or the arteries going to the guts. If there’s no major branches, it’s real easy. You just put a straight sleeve inside it, or a stent graft and, you’ve fixed it.
Host: Okay.
Dr. Kelly: What becomes challenging is if that dilated segment is in the segment where there are major branches going to the arms or the legs or the kidneys. A great example of this is—it’s a lot easier to fix a highway when it’s a straight segment than to fix a highway that has a major intersection. We all deal with intersections as we’re driving down the interstate. You can drive along one side of the interstate with the cones, and you do fine, but where there’s an off ramp, and that’s being addressed, and to keep the highway moving, you’ve got to shift lanes. You’ve got to do this. You’ve got to do that. It’s a real pain. You can imagine doing that in the aorta where you have an area that’s dilated, and you still got to keep blood flow to all those major organs—
Host: Um hmm.
Dr. Kelly: --your kidneys, your bowel so that you can survive this.
Host: Because if you put the traditional stent graft in there you would cover those off—
Dr. Kelly: You’d cover all them up.
Host: Right.
Dr. Kelly: —and you—
Host: You need some exit ramps.
Dr. Kelly: And you would die. You wouldn’t even make it out of the operating room. You would die fairly quickly.
Host: So how was that treated before?
Dr. Kelly: Open surgery. We would cut you open, and we would sew a patch and sew a graft in place.
Host: So, what does this do?
Dr. Kelly: This allows us to fix the same type of aneurysm—
Host: Okay.
Dr. Kelly: —what we call thoracoabdominal, a complex aneurysm. It allows us to fix the same type of aneurysm through a couple little poke holes in the groin and maybe a little incision in the arm. Which means, we’ve now expanded it from only being able to treat people 65, 70 years old to now patients that are in their 70’s and 80’s that maybe have some other medical problems. They may have some lung issues. May have a little bit of renal insufficiency. They don’t have to be that picture-perfect patient, and we can still offer them care.
Host: Because the surgery itself is not as invasive. Is that the issue?
Dr. Kelly: It’s much more tolerable. Well, at least at this early point, that’s what it looks like.
Host: Great. So, tell me—what does this look like? What does this actual device—because I’m trying to imagine you like rolling something into a vein with pieces coming off of it. That’s not it.
Dr. Kelly: So, it’s funny, if you look at commercially competitive devices, those devices all try to mimic what the aorta looks like, and my stance has always been if I try to build a graft that looks like a person’s aorta, then I’m limited by their aorta. So, if you look at the competitive devices, or at least the—and what makes ours novel—that we’re able to get patents on ours is current methodology, which has been a major challenge for us is that current devices look like people’s anatomy. People construct grafts that try to mimic what the aorta looks like. So, when you look at it, you’re like I know exactly where that goes because that goes in the aorta by the blood vessels that go to the guts because that’s what it looks like. The problem with that is we’re trying to fix something abnormal. So, we construct a graft that looks normal in a vessel that’s abnormal.
Host: Okay.
Dr. Kelly: Guess what? They quite often don’t fit because I have an abnormal graft that is contorted—or have an abnormal artery that’s contorted, distorted. It’s not normal anymore. So, to think I’m going to have something that’s normal fit, they don’t frequently. So, our system, on the other hand, doesn’t look anything like people’s anatomy, and I like to refer to ours as a non-anatomical base design.
Host: Okay.
Dr. Kelly: Which means we’re agnostic to people’s anatomy, which means we’re not limited by people’s anatomy, and ours is—we refer to the device as the manifold because what it is—
Host: Okay.
Dr. Kelly: —is—we take and divide the flow above those vessels and then we come off with four little branches that look like a plumber did it off of a manifold with a pipe going here, here, and here, and here. There, at first glance, looks like there’s no rhyme or reason. There is, but at the end of the day, we’re not limited by people’s anatomy, which we hope will expand its applicability for the patients.
Host: Does this look like what you thought it would look like when you started?
Dr. Kelly: Yeah.
Host: Yes.
Dr. Kelly: Yeah.
Host: So, you were on the right track from the get-go?
Dr. Kelly: So, what’s interesting is—I kind of, you know, necessity is the mother of all inventions. You know, you’ve got this patient; they’ve got a problem. You know you can’t put them through this operation. So, you’ve got to come up with a different idea, and from the point and time I saw that patient until we did that first operation was about two weeks. Now, that is two weeks that I was completely checked out. Every waking moment of my time, I was thinking about how do I build this system? How does this system fit into a current deployment system? How do I constrain it? What’s the floor dynamics going to be, look like? All the little details of this device, and this isn’t just a little modification of a currently available device. This was really significant modification to a commercially available device that made it look in a completely different form, and what’s interesting about it is there’s been only really one adjustment to the initial design. That’s been more than 100 patients ago. Now, we’ve now consolidated, or condensed it down into a single device for the shorter aneurysms, but it’s still that same construct.
Host: So, you say two weeks from when you—that you spent every waking moment thinking about this, but, and I just have a few more questions for you, but how long had you had it in the—even subconsciously—and you probably can’t answer if it’s subconscious—in the back of your mind, though, like that you knew you needed to solve this problem? Like what was it that made you say, no, this is it. I’m going all in today—I’m thinking about this.
Dr. Kelly: Well, I mean, this has been a problem for a very long time: figuring out how to treat thoracoabdominal aneurysms and expand it to the population that really needs it, and that’s people in their late 70’s and early 80’s. We started first with an iliac device that we had really pretty good success with. We had our bumps in the road, but overall, we had pretty good success with it, and that was a different methodology, and when this patient came to me in February of 2012, it occurred to me that I could apply that type of technology to the aorta.
Host: So, we’ve achieve this breakthrough designation for this device, and without getting too into the weeds for regular listeners, what does that really mean for patients?
Dr. Kelly: Well, I can tell you what we hope it means.
Host: Sure.
Dr. Kelly: We hope what it means is that we’ll be able to bring this to patients at—at least a little bit earlier point than the classic type of medical device. So, in the grand scheme of things, you can imagine that when we look at a medical device or any type of proposition, it’s always risks and benefits.
Host: Um hmm.
Dr. Kelly: Okay. Well, right now, our device has been designated as a device that can treat an unmet need. So the risk of doing nothing, is what we’re proposing is greater than the risk of us fixing it, and there’s no other real options for these—
Host: Okay.
Dr. Kelly: —patients. So, it’ll meet the unmet need. So, for that reason, we want to get this through an approval process as quickly as we can, but we still cannot sacrifice safety and efficacy.
Host: Absolutely. Okay. Well, thank you very much for sitting down with us today to talk about this. Is there anything I didn’t ask you about that you want to make sure folks know?
Dr. Kelly: I don’t think so.
Host: No? You sigh. (Laughs) Great. Thanks for coming today.
Dr. Kelly: Thank you.
Jacqueline Palfy (Host): Hi. My name is Jacqueline, and I’m here with Sanford Health News. We are talking to Dr. Pat Kelly today about some innovative work that he’s doing. Welcome Pat.
Pat Kelly, MD (Guest): Yeah. Hi. How are you?
Host: I’m pretty good.
Dr. Kelly: Good.
Host: Thanks for coming out today. So, tell me a little bit—you’re a vascular surgeon. Is that the right title?
Dr. Kelly: I am now!
Host: (Laughs) Wow. What did you used to be?
Dr. Kelly: So, in high school, I wanted to be a draftsman, and then I decided I was going to go to college. So, then, I went to college to become an engineer. I really probably wanted to be an architect. Probably I’m more creative than I am analytical, but architects—the hill that architects have to climb is challenging so I decided to be an engineer.
Host: Okay.
Dr. Kelly: It’s much more predictable.
Host: And you’re from South Dakota, is that right?
Dr. Kelly: I grew up in South Dakota, yeah.
Host: Okay. So, you grew up in South Dakota and started a career as an engineer. Tell me what that was like. Was it what you expected?
Dr. Kelly: Well, probably for the first six, eight months, and it really—so when I was in high school, I started working as a draftsman, or at least, a blueprint boy. I ran a lot of blueprints, and then, in college, I worked as a draftsman for an engineering firm in Laramie. That same firm had an office in Brookings. So, I just moved from Laramie to Brookings and started a position as an engineer. Punching numbers, designing bridges—all sounds really cool first few times and then it gets really boring—punching numbers, sitting at a desk all day long.
Host: So, you got a little bit bored with that.
Dr. Kelly: I did.
Host: Is what it sounds like and then what happened?
Dr. Kelly: One day, and I tend to do this, just one day, I just made the decision that I needed to do something different. So, I made that decision, and I decided I would try medical school.
Host: Okay. So, this is what makes you interesting to me is—a lot of people sit there and think, “I need to do something different,” and then they just keep doing whatever they’re doing, but you did not do that. Why medical school?
Dr. Kelly: I don’t even recall.
Host: (Laughs)
Dr. Kelly: I don’t even know anymore. I think it was a challenge. I made that decision—I was going to try to do medical school, and I remember when I went to the university at SDSU and told professors there that I thought I would try to go to medical school, and they’re like, “You’re an engineer. You don’t have any biology. You’re not going to get it in medical school.” I’m like, “I’ll get it. I’ll be fine,” and I did just fine.
Host: And it worked out okay.
Dr. Kelly: It did.
Host: So, you go through medical school, and you graduate and then what happens?
Dr. Kelly: I did a surgical residency. Probably my first few days in residency at the VA, I realized I wanted to be a vascular surgeon.
Host: Okay. Why is that? Did you know you wanted to be a surgeon when you started?
Dr. Kelly: No! I actually—
Host: Okay.
Dr. Kelly: —thought I’d be a pediatrician, and anybody who knows me knows that that is crazy, okay? I’m not patient enough to be a pediatrician—probably could do with the kids, but the parents. It would be awful. It’d be awful.
Host: Well, that’s probably good that you figured out that before you got all the way into that career (Laughs).
Dr. Kelly: I did. I actually figured that out about my first clinical rotation.
Host: Got it. So, you decided to become a vascular surgeon. Why? What was appealing about that?
Dr. Kelly: It was the path of most resistance. It was—at that time, everything was done open. The outcomes were awful. You know, they were difficult operations. It was very technically demanding, but the one thing that was really cool was it was grumpy old men that were really appreciative of what you could do for them.
Host: So, okay. So, part of it was the clientele.
Dr. Kelly: It was totally the clientele. I tell my medical students—you pick your specialty based on the population of people you want to take care of—not the specialty based on procedures because if the procedures don’t become mundane and boring, it means you’re not any good at them.
Host: Oh. Okay. That’s interesting—
Dr. Kelly: Okay?
Host: —because the people are who you’re going to have to deal with over and—
Dr. Kelly: Exactly.
Host: —and over and over.
Dr. Kelly: And that’s—well, and that’s the rewarding part of it. That’s the gratitude. That’s what gives you the reason to get up there and do that miserable operation because you’re going to make that person better, and it’s the type of people—or it’s at least a patient population—you really like dealing with.
Host: Sure. So, grumpy old men is your thing. That’s how—(laughs)
Dr. Kelly: They are not offendable.
Host: (Laughs). That’s probably good. So, tell me how your background as an engineer influences your thinking as a surgeon.
Dr. Kelly: Well, I think as an engineer, you know, an engineer is a degree in problem solving, you know. You’re faced with a problem; you break it into its smaller root problems, and you solve one problem at a time. It’s kind of like The Martian, you know, the show The Martian, you know. One problem at a time, and once you solve one problem, you move to the next problem, and I like that about vascular surgery. Vascular surgery is very much “solve one problem at a time,” and it’s plumbing. It’s really simple.
Host: Um hm.
Dr. Kelly: It’s not scholastically or academically challenging. You’ve got blood flow in. You’ve got blood flow out, and you’ve got to have a pipe in between. It’s not real difficult. It can be technically very challenging. So, you need to know what you’re doing, but it has great opportunities for problem solving.
Host: So, it’s really the same mindset for both kinds of career; I mean that’s—
Dr. Kelly: Or at least I made it that way.
Host: Yeah. (Laughs). You make your own luck in this game, right? That’s what—
Dr. Kelly: To some extent.
Host: Absolutely. So, you have this passion for problem solving—it sounds like. So, that has led to a fair amount of inventions through your work with Sanford, right? How many patents do you have? Do you know off the top of your head?
Dr. Kelly: I don’t. I think it’s over 200 now worldwide.
Host: Which is pretty amazing. What was your first patent in?
Dr. Kelly: Well, the first patent I filed was back in 2008, which never went anywhere because I didn’t understand the process. Since then, I think we first filed a whole bunch of them in 2012.
Host: Okay.
Dr. Kelly: Those were all revolved around stent grafts.
Host: Okay, and this what—a little bit about what we’re talking about today, right?
Dr. Kelly: Um hmm.
Host: Stent grafts.
Dr. Kelly: Yes.
Host: So, tell me, as a regular person here, what is a stent graft?
Dr. Kelly: So, how I like to explain to my patients is a stent graft—I mean, it’s a construct of a metal scaffolding like chicken wire with cloth or some type of impermeable material over the top of it. That’s—
Host: Okay.
Dr. Kelly: —in the kind of the gross simplistic manner. So, you can imagine if I’ve got a pipe and the pipe is bad, either because it has a hole in it, like an aneurysm, or it’s just irregular and it’s clogged. If I can go inside that pipe and put a new pipe inside it, and either re-expand it or have it expand on its own, I re-line the pipe and have it work well, and that’s all a stent graft does, and that’s all a stent does. It’s just relining a pipe. That pipe happens to be our arteries or our veins.
Host: Um hmm. It’s very weird to me to like think about that, right, that you’re building internal scaffolding for veins—so that’s right?
Dr. Kelly: And arteries.
Host: And arteries. Okay. I want to talk—tell me a little bit about this device that you’ve created that recently received fast tracking through the FDA. We’ll get into what that means with the FDA in a minute, but what exactly is this device?
Dr. Kelly: So, the aneurysm that most of us think about—
Host: Define aneurysm.
Dr. Kelly: I will.
Host: Honestly, I think some people don’t know what that is.
Dr. Kelly: Sure.
Host: I tried to tell my kids today what I was doing, and they’re like, “What’s an aneurysm?” and I’m like “Ummm, I’m going to have a better answer at 5”. (Laughs)
Dr. Kelly: So, it’s an abnormal dilation of an artery or vein, but it’s abnormal dilation of a blood vessel. So, you can imagine you have a vessel that’s—let’s say—it’s a half inch diameter. Then, all of a sudden, it expands up to three inches in diameter, okay? You can imagine if that was like a garden hose that expanded three or four times it’s—it’s going to be weak, and it’s going to most likely start leaking at that spot in the garden hose. Well, an aorta’s no different. It’s a pipe that has a fixed diameter, and there’s a segment that may—dilates up, and if it’s a straight segment that doesn’t have any major branches or, any, you know, like the renal arteries or the arteries going to the guts. If there’s no major branches, it’s real easy. You just put a straight sleeve inside it, or a stent graft and, you’ve fixed it.
Host: Okay.
Dr. Kelly: What becomes challenging is if that dilated segment is in the segment where there are major branches going to the arms or the legs or the kidneys. A great example of this is—it’s a lot easier to fix a highway when it’s a straight segment than to fix a highway that has a major intersection. We all deal with intersections as we’re driving down the interstate. You can drive along one side of the interstate with the cones, and you do fine, but where there’s an off ramp, and that’s being addressed, and to keep the highway moving, you’ve got to shift lanes. You’ve got to do this. You’ve got to do that. It’s a real pain. You can imagine doing that in the aorta where you have an area that’s dilated, and you still got to keep blood flow to all those major organs—
Host: Um hmm.
Dr. Kelly: --your kidneys, your bowel so that you can survive this.
Host: Because if you put the traditional stent graft in there you would cover those off—
Dr. Kelly: You’d cover all them up.
Host: Right.
Dr. Kelly: —and you—
Host: You need some exit ramps.
Dr. Kelly: And you would die. You wouldn’t even make it out of the operating room. You would die fairly quickly.
Host: So how was that treated before?
Dr. Kelly: Open surgery. We would cut you open, and we would sew a patch and sew a graft in place.
Host: So, what does this do?
Dr. Kelly: This allows us to fix the same type of aneurysm—
Host: Okay.
Dr. Kelly: —what we call thoracoabdominal, a complex aneurysm. It allows us to fix the same type of aneurysm through a couple little poke holes in the groin and maybe a little incision in the arm. Which means, we’ve now expanded it from only being able to treat people 65, 70 years old to now patients that are in their 70’s and 80’s that maybe have some other medical problems. They may have some lung issues. May have a little bit of renal insufficiency. They don’t have to be that picture-perfect patient, and we can still offer them care.
Host: Because the surgery itself is not as invasive. Is that the issue?
Dr. Kelly: It’s much more tolerable. Well, at least at this early point, that’s what it looks like.
Host: Great. So, tell me—what does this look like? What does this actual device—because I’m trying to imagine you like rolling something into a vein with pieces coming off of it. That’s not it.
Dr. Kelly: So, it’s funny, if you look at commercially competitive devices, those devices all try to mimic what the aorta looks like, and my stance has always been if I try to build a graft that looks like a person’s aorta, then I’m limited by their aorta. So, if you look at the competitive devices, or at least the—and what makes ours novel—that we’re able to get patents on ours is current methodology, which has been a major challenge for us is that current devices look like people’s anatomy. People construct grafts that try to mimic what the aorta looks like. So, when you look at it, you’re like I know exactly where that goes because that goes in the aorta by the blood vessels that go to the guts because that’s what it looks like. The problem with that is we’re trying to fix something abnormal. So, we construct a graft that looks normal in a vessel that’s abnormal.
Host: Okay.
Dr. Kelly: Guess what? They quite often don’t fit because I have an abnormal graft that is contorted—or have an abnormal artery that’s contorted, distorted. It’s not normal anymore. So, to think I’m going to have something that’s normal fit, they don’t frequently. So, our system, on the other hand, doesn’t look anything like people’s anatomy, and I like to refer to ours as a non-anatomical base design.
Host: Okay.
Dr. Kelly: Which means we’re agnostic to people’s anatomy, which means we’re not limited by people’s anatomy, and ours is—we refer to the device as the manifold because what it is—
Host: Okay.
Dr. Kelly: —is—we take and divide the flow above those vessels and then we come off with four little branches that look like a plumber did it off of a manifold with a pipe going here, here, and here, and here. There, at first glance, looks like there’s no rhyme or reason. There is, but at the end of the day, we’re not limited by people’s anatomy, which we hope will expand its applicability for the patients.
Host: Does this look like what you thought it would look like when you started?
Dr. Kelly: Yeah.
Host: Yes.
Dr. Kelly: Yeah.
Host: So, you were on the right track from the get-go?
Dr. Kelly: So, what’s interesting is—I kind of, you know, necessity is the mother of all inventions. You know, you’ve got this patient; they’ve got a problem. You know you can’t put them through this operation. So, you’ve got to come up with a different idea, and from the point and time I saw that patient until we did that first operation was about two weeks. Now, that is two weeks that I was completely checked out. Every waking moment of my time, I was thinking about how do I build this system? How does this system fit into a current deployment system? How do I constrain it? What’s the floor dynamics going to be, look like? All the little details of this device, and this isn’t just a little modification of a currently available device. This was really significant modification to a commercially available device that made it look in a completely different form, and what’s interesting about it is there’s been only really one adjustment to the initial design. That’s been more than 100 patients ago. Now, we’ve now consolidated, or condensed it down into a single device for the shorter aneurysms, but it’s still that same construct.
Host: So, you say two weeks from when you—that you spent every waking moment thinking about this, but, and I just have a few more questions for you, but how long had you had it in the—even subconsciously—and you probably can’t answer if it’s subconscious—in the back of your mind, though, like that you knew you needed to solve this problem? Like what was it that made you say, no, this is it. I’m going all in today—I’m thinking about this.
Dr. Kelly: Well, I mean, this has been a problem for a very long time: figuring out how to treat thoracoabdominal aneurysms and expand it to the population that really needs it, and that’s people in their late 70’s and early 80’s. We started first with an iliac device that we had really pretty good success with. We had our bumps in the road, but overall, we had pretty good success with it, and that was a different methodology, and when this patient came to me in February of 2012, it occurred to me that I could apply that type of technology to the aorta.
Host: So, we’ve achieve this breakthrough designation for this device, and without getting too into the weeds for regular listeners, what does that really mean for patients?
Dr. Kelly: Well, I can tell you what we hope it means.
Host: Sure.
Dr. Kelly: We hope what it means is that we’ll be able to bring this to patients at—at least a little bit earlier point than the classic type of medical device. So, in the grand scheme of things, you can imagine that when we look at a medical device or any type of proposition, it’s always risks and benefits.
Host: Um hmm.
Dr. Kelly: Okay. Well, right now, our device has been designated as a device that can treat an unmet need. So the risk of doing nothing, is what we’re proposing is greater than the risk of us fixing it, and there’s no other real options for these—
Host: Okay.
Dr. Kelly: —patients. So, it’ll meet the unmet need. So, for that reason, we want to get this through an approval process as quickly as we can, but we still cannot sacrifice safety and efficacy.
Host: Absolutely. Okay. Well, thank you very much for sitting down with us today to talk about this. Is there anything I didn’t ask you about that you want to make sure folks know?
Dr. Kelly: I don’t think so.
Host: No? You sigh. (Laughs) Great. Thanks for coming today.
Dr. Kelly: Thank you.