Kurt Amplatz Narrator Kirk Jeffrey Interviewer October 23, 2000 AGA Medical Golden Valley, Minnesota KJ: This is Kirk Jeffrey on October 20, 2000, and this afternoon I will be interviewing Dr. Kurt Amplatz at his office at AGA Medical, in suburban Minneapolis, in Golden Valley, Minnesota. Dr. Amplatz, thanks a lot for agreeing to be interviewed this afternoon. Could we start by your telling me a little about your life, your education, how you came to be located here in Minnesota, and some of the principal activities of your career over the years? That s a pretty big question. KA: Well, originally, I came from Austria, and things were going very badly in Austria after the war [World War II]. We were occupied by Russia. We had very little to eat; as a matter of fact, 800 calories a day. I had been studying in Fribourg, Switzerland; Paris, France; and Zurich, Switzerland, so I thought it may be interesting to go to the United States. My intention was only to stay one year, but after one year, I liked it so much that I took a year s internship at Brooklyn, St. John s Hospital in Brooklyn. Then I was looking for a residency program and I wrote thirty letters, and I got only one answer. That was the Mayo Clinic. So I flew there for an interview in the wintertime. I remember I landed in Rochester and it was snowing and people were so slow, and they talked so slowly, and I thought, I will never survive in a place like this. So I had that interview and they asked me all kind of specific questions: What would you like to specialize in, in radiology? and, What do you think about isotopes and radium? Well, anyhow, they turned me down. So I already had my return ticket, by boat, which at that time was $300, I remember, and just the day before I left, I got a telephone call. This is Mrs. Shapiro in Detroit. Hi, how are you, Mrs. Shapiro? Well, are you still interested in a residency? I said, Yes. How much do you pay? 13
$450 a month. So I said, Well, I ll take it. So I took my residency in Detroit, Michigan. KJ: What hospital was that? KA: That was Receiving Hospital. Now I think it has a different name. KJ: Was this about 1948? KA: No, no. It s 1954. 54, I went to Detroit. The second largest trauma hospital, so it was really an experience, a good experience, but it was very rough. When we were on night call, we had to work the next day and we had to cover a private hospital across the street as X-ray technicians. There were virtually only foreigners, almost only foreigners at that time. Foreigners were in demand, because they didn t have enough American physicians. As a matter of fact, my internship at Brooklyn, we had only one American intern, and that was a lady, and it was really unheard of at that time to have a female physician. But anyhow, I took that residency and then I took my boards. My board examiner was Leo Riegler, who at that time was the number-one radiologist, probably, in the world. He was a chief at Minnesota. He examined me and I think I didn t do very well, but I passed, apparently, and he told me, You want to come to Minnesota? and I said yes. He asked me, Are you interested in hearts? I said, Not at all. Well, he said, this year that s the only position we have. So I said I d take it. So I started in Minnesota for $5,000 a year, as a so-called instructor, and, fortunately, I landed in the [Variety Club] Heart Hospital [part of the Medical School of the University of Minnesota], which was the only heart hospital in the United States, or in the world, funded by artists, not federal money. And so I had to start out with the heart, and I learned a lot about hearts, and it interested me. Then they promoted me to assistant professor, then associate professor, and finally full professor, in radiology. And then immediately I started to develop devices. At that time it was all for radiology. I became acquainted with the scientific apparatus shop at the University, which at that time was the biggest machine shop, university-owned machine shop, in the country, and one of the machinists was working for me full time since 1957, he just retired. Then I devised many things for neuroradiology. I worked four years in neuroradiology and then in uroradiology for several years. In my old days, now I came back to cardiac radiology. All the 14
devices I designed were made by companies, and these companies are extremely slow to move. It takes them half a year to get a prototype, and usually the prototype is far away from any production instrument. So I got frustrated and I told myself I had to have my own company in order to get things moving. So I started a company together with my son, which is called Kamca, standing for Curtis Amplatz, and my son s name is Curtis Amplatz. We rented a warehouse space on University Avenue, and I bought a machine shop and I bought a little oven. My son was knowledgeable in working with nitinol because he worked at Flexmedics [Corporation]. Flexmedics is a local company that made arch wires made out of that alloy nitinol, which has unique properties. I wanted to enlarge the company to take in more people and make it bigger, but my son just didn t want to have anybody else. So I realized I cannot work with him, and I split up with him and started this company here. KJ: AGA. KA: AGA. Which stands for [Kurt] Amplatz, [Franck L.] Gougeon. That s my son-in-law, who s the vice president, and Michael Afremor. He s a Russian engineer. My son-in-law is a French emigrant. KJ: Kamca split up. When was that? KA: Oh, that was eight years ago, or something like that. KJ: And AGA was founded almost immediately? KA: AGA was founded five years ago or something like that, or six years now, six years now. KJ: So 1994, approximately? KA: Yes. KJ: Back in the days when you were just moving up in radiology at the University, in the 1950s, did you have much contact with the Department of Surgery and the innovative work going on then in heart surgery? KA: Oh, yes. Tremendous contact with [Dr.] C. Walton Lillehei. I did all his patients, all the angiograms for C. Walton. He did not send anything to the cardiologists. I m not a cardiologist; I m a radiologist. And also we did all the angiography for his brother, [Dr.] Richard Lillehei, who, unfortunately, died while jogging in Florida. These were two outstanding pioneers, of course. C. Walton is more known. Also, I did all the angiograms for [Dr.] Richard Varco, all the great pioneers of cardiosurgery, and general surgery. I did all the angiograms for [Dr.] Paul 15
Dwan, who s a pediatric cardiologist. We did all the coronary arteriograms. Well, we did everything. KJ: Coronary angiography was just coming in in the fifties, isn t that right? KA: Yes, in the fifties. There was a technique that developed here, actually. They pioneered coronary angiography here at the University of Minnesota, with Richard [Lillihei] and they were surgeons, where they had the so-called phasic dye injection, where a contrast medium was injected when the aortic valve was closed. And then Peterson, who was my chief, he told me, Well, you know, there s that guy [Dr. F. Mason] Sones, at Cleveland Clinic, and he just sticks a catheter into the coronary artery and injects a contrast medium selectively. And I thought, well, I think that is a good idea. At that time, the Sones technique was well developed, which was a cut-down on the brachial artery. KJ: So did you learn catheterization in order to do this? KA: Well, yes, catheterization, I learned, actually, by myself. In 1958, there was a World Congress of Radiology in Munich, and after that World Congress, I flew to Sweden to watch [Dr. Sven-Ivar] Seldinger, who was the pioneer of percutaneous catheterization, of course, actually pioneered as his chief said, actually, the technique comes from Minnesota. He was here visiting Minnesota, and they took him through the labs and they were experimenting with vein strippers, which is identical to our modern guide wires we are making now. As a matter of fact, my mechanic made these vein strippers. He got back to Sweden, and Seldinger was a young assistant or whatever he was, and he told him he should try that, said it s a good idea. But anyway, he deserves all the credit to have developed the percutaneous catheterization technique. KJ: You were working in radiology and doing a lot of catheterization and angiography in the late fifties and sixties. Were you already beginning to be involved with inventing devices at that time? KA: Oh, yes. KJ: What were some of the early things you worked on? KA: The earliest thing was improving the Seldinger technique. I watched Seldinger do one case with extreme difficulty, I remember, in Stockholm, Sweden. I bought myself the equipment, which was a guide wire, a needle, and a coil of polyethylene tubing. I went back to Minnesota and made my own catheters, and we started using this equipment. Well, one problem with the Swedish guide wire, from Kifa Company, was that the tip would break off, and we had so many cases that the surgeons would actually publish a paper on surgical 16
removal of iatrogenic guide wires. So I talked to my mechanic, that we had to solve that problem, and he did. We made the flexible tip longer, and in addition to the core wire, we had a cable, so that made the wire safe. So that was the first development. Then also the needle was extremely traumatic, made out of steel, so we made a special needle with a catheter tubing over the needle, which was more flexible and more benign to the artery. These were the first developments, but then there were many, many, many, many more. KJ: How many patents do you have? KA: Well, not too many. They claim I have a lot of patents, but most of the patents I have never heard of. They were taken out by companies. The guide wire, for instance, was patented by Cook, Incorporated. My technician, who worked with me for several years, went to Oregon to [Dr. Charles T.] Charlie Dotter, who is a pioneer in interventional radiology, and he brought these guide wires. Charlie Dotter was a good friend of [William] Cook, the president of Cook Company. It s one of the biggest companies making this type of equipment. And they patented the guide wire and made it and so on and so on. All the equipment I made was patented by companies that made that equipment. Even now, I m not interested in patents although if you look over there [on the wall] there are several hanging up there. But Franck [Gougeon], who is my business manager, he s very interested in the patent stuff. KJ: I noticed, in preparing for this interview, a company called Microvena [Corporation], that manufactures a product called the Amplatz Goose Neck Snares and Microsnares. Are those something of your invention? KA: Right. Well, Microvena was started by a fellow called Mazzocchi, Rudy [A.] Mazzocchi. Rudy Mazzocchi happened to be the boyfriend of my daughter, and he started a company, financed originally by Phillips, which is an extrusion company in Wisconsin, a big company. They made him president of Microvena, a name he invented himself, and Rudy Mazzocchi did not have one single product. So I tried to help my daughter and also Rudy, who was a friend of mine, and I talked to my mechanic and said, What can we give this guy? He doesn t have a product, he s starting a company. So he said, Why don t you give him the snare? You use a snare once a month, maybe. So we gave him the snare, and the snare developed into an extremely successful product. As a matter of fact, they have a world monopoly on these snares. And then we worked on mechanical thrombectomy, that is, dissolving clots mechanically, and we gave that to them. What else? 17
KJ: They list another product line called Hy Tek Ultra-Select, and Flex-Finder Nitinol Guidewires. KA: Okay. This is a guide wire which was also developed by us, together with Flexmedics. That s that company that was making the arch wires for orthodontistry. They never wanted to work with me, but they worked, then, with Microvena. Flexmedics was the sister company of Microvena, financed largely by Phillips. Phillips owned most of the stock. So they re making that guide wire. Flexmedics, I think, was dissolved, and now Microvena is making all of the products, except the arch wires, I think. They went out of all of that business. KJ: They apparently have other products, too, that are generally somewhat in the same line. They have a microcatheter. KA: Yes. They bought a catheter company in California and they made a microcatheter which never took off. KJ: To go back to the snares, the Amplatz Goose Neck Snare, it says that that s a product for retrieval and manipulation. Can you explain a little bit about what that kind of thing does? KA: Yes. Well, that s very well said. Retrieval is the number-one application. There are cases where guide wires or catheters break in the body. Previously, of course, we had to call the surgeons to retrieve them. Now with that snare technique, you can go in percutaneously, without a cutdown or any wound, and just snare it and pull it out. KJ: So there s a loop on the end? KA: It has a loop at the end, and it has a right-angle loop, which is important, and that means it s at right angle with the axis of your catheter, and you just try to entrap it, pull the catheter up, and close the loop and pull the catheter out. This is done in thousands of cases. And also now with that stent business, particularly in coronary angiography, when these stents are misplaced or migrate, they can be pulled out with a microsnare. Microsnare is identical, but it s just smaller. KJ: With something like a stent, or a pacemaker lead, which is placed chronically and where there may be tissues that develop around the device, can it still be removed in this way? KA: Most cases, they can still be removed, but you re correct. All these foreign bodies will grow in and will become covered by fibrous tissue, or endothelium, as we call it. KJ: Before the interview began, I was looking at the Septal Occluder. This, I guess, is the main product currently for AGA Medical? KA: That is the main product, correct. 18
KJ: Is this in clinical trials or is it in general release yet? KA: It was in clinical trials in the U.S., so-called phase one and phase two, which was completed, and the application for PMA, that s pre-market approval, was mailed to the FDA [Food and Drug Administration], and they came right away to examine our company. As a matter of fact, they re still here. They were here today. They re going to be here Monday and Tuesday, and they were here all week. So hopefully we ll get the approval in the U.S., but this we don t know for sure. It is, however, approved in Europe. It s called C.E. Mark, and it is approved in Canada and Australia and obviously in all Third World countries, because they do not have these regulations. It s also approved in Mexico. KJ: When the FDA is making a determination, they re interested not only in the safety and effectiveness of the product, but in the manufacturing facility. KA: Correct. KJ: Are these manufactured here, on site? KA: Here on site. Yes, I can show you the facilities. Oh, the things involved with an FDA inspection are something horrendous. It s a nightmare. KJ: With this occlusion product I m looking at the pictures of it it looks a little like a flower or a mushroom on a stalk. And when it s advanced up a vein I guess it goes through a vein, right? KA: It goes through a vein, correct. KJ: To the right and left well, to the left atrium, and then it s pulled through the septal opening. Does it collapse downward or bend down like an umbrella as it s being pushed up through the vein, or does it remain fully extended? KA: No, it is introduced through a very small tube. Then, of course, it will elongate, but when you push it out, the umbrella will open up, and that is due to the so-called super elastic property of nitinol, that you can do that. It does not take a set, in other words. Most other metals will take a set. KJ: I notice in some of the case reports in this literature that many of the patients who received these are infants or young children. KA: Young children. KJ: As the child grows and the heart grows, will the defect itself enlarge, meaning that you have to replace this with a larger occluder? 19
KA: No. We know from the surgical technique, of course, which is fifty years old, as a matter of fact, pioneered here by C. Walton Lillehei in the early fifties, that the heart will grow normally and the septum will grow normally and it does not have to be replaced. KJ: It s a remarkable thing not to have to open up the chest and open up the heart to replace or to repair a defect. KA: Right. It has, of course, tremendous advantages over surgery. Number one, of course, all the trauma of surgery, the pain, and then no scar, which is extremely important for Third World countries, particularly India, where ladies with scars have difficulty finding husbands. And very short hospitalization. Actually, they could go home the same day, but most people will keep the patient overnight. And then the tremendous financial advantage, of course. Surgical closure of an atrial septal defect in this country is about $47,000, and the device will sell in this country probably for about $3,500. KJ: Could one imagine a similar device for a ventricular defect? KA: Correct. We are actually the only company making specific devices for various defects. We re making the atrial septal defect occluder and we re making the patent foramen ovals, or PFO, occluder, which is differently constructed. And then we re making a device for occlusion of patent ductus arteriosus. And then we re making a different device for occlusion of muscular ventricular septal defect. And now we are starting occlusion of membranous ventricular septal defect, which is the most common form of congenital heart disease. KJ: You re going to put the heart surgeons out of business. KA: Well, they re still going to have some. There are many things left we cannot do, but I think [surgical] closure of atrial septal defects, surgery for atrial septal defects of the secundum type, muscular ventricular septal defect, and PFO, is only of historic interest. There are still pediatric cardiologists who will send their patients to surgery. But in Germany, for instance, where we have sixty institutions, this is not done anymore. In this country, yes, because the device is not available. We have about 5,000 implants. KJ: Worldwide? KA: Worldwide. These are registered implants, and we know that most people and many physicians do not fill out the cards and send it to us, because we are selling about 2,000 introduction systems that goes with the introduction of the device per month. So there are many, many more cases. KJ: That never get reported back to you. 20
KA: That never get reported back. People just don t want to do paperwork. I don t like to do paperwork, either. KJ: I notice that you ve co-authored some papers. Do you have students from the University [of Minnesota], graduate students or medical students, that you ve taught and also who have collaborated with you? KA: Oh, of course. We always have physicians in our lab who are board-certified radiologists, and I let them write the paper and then I rewrite it, and I let them also [appear] as principal author. I put my name at the end and now I don t even add my name on it anymore, because I have more than 700 publications and I don t need more publications. KJ: Have some of your students gone on to inventive work away from Minnesota? KA: Well, actually, as far as inventive work is concerned, actually, only one. That s [Dr. Andrew H.] Andy Cragg, who is working over at St. Mary s. Or actually now it s called Fairview, and we [University of Minnesota Hospitals] are part of Fairview. He made some innovations and important contributions. KJ: Other radiologists or young apprentices, if I can call them that, have gone on in more or less traditional radiology? KA: Many of them became chairmen of radiology departments, and some of them stayed in academic radiology. I think the majority still went into private practice. KJ: It strikes me that a lot of these technologies are used by invasive and interventional cardiologists, mostly. KA: Yes. Well, as I told you, we used to do all the heart cases. But as a matter of fact, we lost the entire field of cardiology to the cardiologists, and they re getting very good at it. I trained one of the pioneers of cardiology, [Dr. James] Jim Lock, who was working at Boston Children s [Hospital], and he learned very fast and he s training other people and now cardiac work is, I would say, exclusively, cardiology. KJ: Well, this happens frequently when a new kind of technology comes into use. There may be a kind of struggle over what kind of specialist would use it. KA: Radiology has lost cardiology all over the world, particularly in the United States, because it s a financial incentive, of course, to give up a patient to another specialty. Only in Lithuania, the radiologists are still doing coronary angiography and coronary angioplasty, because in the socialistic countries there is no reward for doing cases. KJ: So cardiologists have no great incentive. 21
KA: They have no great incentive and let the radiologist do the dirty work. KJ: Yesterday I visited the Minneapolis Heart Institute and saw the electron beam CT [computed tomography imaging] scanner, and the doctor who demonstrated that was a radiologist. KA: Well, we still have in this country the CT and NMR, [nuclear] magnetic resonance, usually under radiology, but there s more and more push for specialized cardiac MR, and this probably will be done by cardiologists. For instance, we have lost the field of ultrasound, cardiac ultrasound, which is a very important imaging technology to cardiology. KJ: Is ultrasound the same as echocardiography? KA: Same thing. Just a different name. KJ: Yes, they have a whole subspecialty in echo. You ve had a varied career in radiology, university research, invention, business, corporate, founding companies. Nowadays, with very large health-care providers, we re also seeing that the manufacturers are getting larger and they re gobbling up small companies. I saw in the paper today that Medtronic just made another acquisition, out in California, a small company that just had one product, really. And I guess that s because they have to market or present these products to a purchasing agent or a purchasing department. KA: Of course. KJ: They re not interested in dealing with little, tiny companies. KA: Right. KJ: Do you foresee that companies like AGA or Microvena will have to face problems in that way? Do you expect that small companies will get picked up by the big guys eventually? KA: I cannot speak for Microvena, but I know that the previous president, Rudy Mazzocchi, was building up a humungously expensive company, with the intent to sell it. He was proud to say, I m the youngest president of a company in the United States, and he tried to sell his company, and he tinkered with Medtronic and SCIMED and whatever have you, but never succeeded. So I do not know what the future of Microvena is. As far as this company is concerned, as long as I live, nobody will buy us. We are not interested in business. At least I m not interested in business; I m just interested in developing products and helping people. There s one company that tried to buy us: that s our competitor. And you 22
know, if a competitor buys you, there are two incentives. Number one is kill the competitor, to put the other product on the shelf. Number two is, of course, to take the other product over and make more money. We told them we are not interested in selling anything, so now they are suing us for a patent infringement, which they are going to lose. But that s how industry works. First, they try to buy you, then they sue you. KJ: There seems to be an immense number of lawsuits in medical device companies. KA: It s an ugly industry. I was not familiar with industry, of course. I m a university man. But it s an ugly, ugly, competitive business, with all kinds of rumors that are spreading, trying to hurt you. It s not a pleasant atmosphere, to work in industry. KJ: I ve finished writing a book recently about the pacemaker defibrillator industry. Those are very good companies, but they compete quite vigorously, to say the least. KA: It s a vicious business. The pacemaker, of course, comes also from the University of Minnesota. Dr. C. Walton Lillehei had these patients with ventricular septal defects and they had heart block, and he used the Grass Stimulator, which was an external fibrillator using, I think, about sixty volts. Obviously, the patients got burned skin. KJ: They were often children, or even infants. KA: Right. Infants, yes. Then he had a repairman, Earl Bakken. Earl Bakken was a repairman of our EKG [electrocardiogram] machines. At that time they broke down a lot. And then he [Lillihei] said, Earl, I have a project for you. Why don t you get me a stimulator we can wear on the patient s belt, and I will sew in two leads into the heart, and we just apply the current directly to the heart. And Earl said, Well, I ll make it. And I think a month later, he came up with that Medtronic at that time, they didn t have the name Medtronic, but stimulator, internal [external] stimulator the patient was wearing on his belt and he had a dial. He could even dial his heart rate if he wanted to. KJ: When they realized that that should happen, they started recessing the dial so that you needed a screwdriver, at least. KA: Right, you do. KJ: A little too easy to KA: To change it. And I still remember we were doing a heart cath [cardiac catheterization or angiogram], and that time, obviously, it was all in the dark, because the TV [television] was not invented for X-ray. We were doing that heart cath and one guy stuck his head through the door and he said, Does anybody want to buy stock? 23
And we said, Well, what s the company? He said, Medtronic. Medtronic. How much a share? One dollar. And nobody bought stock, except [Dr.] C. Walton Lillehei. He knew the future of that invention. KJ: Yes, it s been an amazing thing. Today, as you continue research at the University [of Minnesota] and also have AGA Medical, roughly how much of your time do you devote to each of these activities? I know they re related, of course. KA: Of course they re related. We have the advantage to have a research lab at the University, which is financed by AGA, so it is not university money, it is not government money. It s private money, company money. But this financial commitment is not restricted to our products. It covers all the other disciplines, the orthopedics and whatever have you at the University, as well as company research of other companies, because we pay the technician and we pay the doctors. But for us it is very convenient. We can test new products, experimentally. KJ: So, in a sense, your research facility for the earliest stage of product development for the company is actually located at the University. KA: At the University. As a matter of fact, in that lab, there worked forty-nine companies. Now, 3M, Medtronic, SCIMED, AngioMed, all these companies, of course, for them, were not paid to finance a research laboratory, so they do that at the University. KJ: So the question of how you spend your time, it s premised on the idea that these are two separate things, but they re really not two separate things. KA: No, they re not, no. It s a matter of convenience, and I think it has worked out very well, and what people do not realize, it has worked out very well for the medical industry of Minnesota. KJ: Yes, indeed. KA: Because everything medical, virtually everything medical, comes from the University. KJ: In addition to the technicians and engineers who are employed at the lab, I guess there must be graduate students in biomedical engineering who are also working on helping and learning the ropes there. 24
KA: Yes. Unfortunately, we do not have too much contact with bioengineering, although what we are doing is bioengineering. KJ: Indeed. KA: But it s a different department. We have some contact, I shouldn t say that, but actually the bioengineers never come over. We have very good contact with the veterinarians from the St. Paul campus. They come over with all their pet dogs with congenital heart disease, and we do cases for them. They re very active and very academic. I think it s an excellent the veterinary medicine at the University is an excellent department. KJ: So the bioengineers have their own shop somewhere? KA: I don t think they do much animal work. I don t know what they do. It s more bench testing, I guess. Maybe they have their own lab. I do not know. But they do not come over to our lab. What we have in our lab are cancer people, orthopedic people, urology people, gastroenterology. That s about it. And radiology. KJ: Where is your lab located? KA: In the KE Building. KJ: Just the letters, KE? KA: KE, yes. KE Building is a research building. There s only research. It s a huge building, and there are only labs. Cancer research and biology, whatever. KJ: Well, Dr. Amplatz, I want to thank you for talking to me this afternoon. KA: Oh, that s great. It was a pleasure. KJ: You ve had an exciting career and contributed a great deal. KA: The bad thing is, it s the end of the rope. KJ: Not quite yet. KA: [Laughter] But I enjoy it. I have less time now than I ever had. KJ: You re keeping busy. KA: I m keeping busy and going to college again. 25
KJ: What are you studying? You re doing some coursework? KA: Machining, machining. Courses at Century College. And then I m trying to push these guys. But we have a very good group. They re all young and enthusiastic and I think they re all very happy. We have fantastic people sewing. All this is sewn by hand. I can show you some of the KJ: If you have a moment, I d really like to look around. KA: These are all Orientals. KJ: Immigrants. KA: Immigrants, yes. Hmong and Chinese. KJ: That s really great. These products certainly look like they re going to revolutionize certain aspects of heart surgery. KA: Yes, I think they have already. KJ: There seems to be a general tendency toward trying to have less invasive, less traumatic procedures. KA: Of course. But it s not easy to do. That s a so-called Class Four implant, and that s the most difficult to get [FDA] approvals for. It s like drugs, same thing. KJ: Yes, these are life-sustaining and potentially life-threatening. KA: And of course, we do not know the long-term outcome of these implanted devices. Now, you ve had at least 5,000 people running around with these foreign bodies in the heart. KJ: What s the longest time with these things implanted? KA: The longest time with an implant our competitors, they were before us, they are looking back to about ten years. We only have about five, six years implantation. KJ: Well, at one point the pacemaker had a similar situation. KA: Of course. KJ: Very few people had more than three or four years of experience. 26
KA: Well, I lost my own father because of a cardiologist who took care of him, who did not want to put in a pacemaker. KJ: Because they were unproven, sort of? KA: They had a failure rate of 65 percent. Wire breakage. KJ: Thank you so much for taking time to talk to me today, Dr. Amplatz. 27