Shortly before this interview was held, Heliane Canepa was named president of Schneider Worldwide. Ms. Canepa has been with Schneider almost since it was founded in 1977, when it started manufacturing the first angioplasty balloons for Andreas Gruentzig. This interview was conducted in November 1996 by Burt Cohen.

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Q: Tell me what it was like working in the beginning days of angioplasty.
Canepa: Well, we started in a garage. We had a production team of ten people. And, of course, there was no clean room. We made about five catheters a week. And we were not allowed to sell one catheter to a doctor who didn't show us a certificate from Andreas Gruentzig, a training certificate. So, we had a window in this garage and we opened it. We gave the catheter and we wanted cash — Swiss francs — not U.S. dollars, no checks. And we sent the doctors back to the bank so that they could bring Swiss francs. And at that time they were very grateful, you know.

We didn't need a marketing and sales department. We didn't have, of course, a clinical or regulatory affairs, no lot number, no batch number. There was the coffee, the cigarettes, and the cooking pot — we made the balloons in there — and we were very proud when we had five pieces of catheters. So it was not a big thing. We never thought that we'd grow that much.

Q: You said you didn't have anyone in charge of regulatory. But you did....
Canepa: Of course, it was Andreas.... Andreas was really a very cautious man and he had a very cautious approach to it. He trained all doctors on live cases. He was a very good teacher. And he didn't allow us to sell [catheters] freely to everybody. He had absolute control over what was going on. About all patients in every country. They were all reporting to him. They were all giving him the data. So he was the best clinical regulatory department we could ask for. And, of course, our best marketing department too.

Q: What was his motivation?
I think he just was a winner — a winner personality. And very determined, very demanding. Got on our nerves sometimes. But fascinating. He was obsessed with his invention. And he wanted it to work. He was a very serious character, very good-hearted, but very demanding. He just wanted things — like he wanted the prototypes, he wanted it safe. He was a very technical person, so he could talk to our engineers on a technical basis, which was very nice, of course, because he knew materials, he knew what we were talking of. I think he was just driven by his vision to have this thing going.

Q: In the beginning, who came?
Canepa: Those were the pioneers really, because the material was awful. Today nobody would touch it anymore. It had no profile, no torquability, pushability — all those words were not known! So there were really cardiologists coming from all countries, really the pioneering cardiologists, who believed in it. And there still was the fight going on against surgeons because [the cardiologists] didn't get enough patients. So in a lot of countries they couldn't even start, because the patient was not there.

That was a real pioneering group. And you could feel it. Innovative. I'm so glad I was part of it then because this was really something, everybody...exciting. Exciting things! It was not normal.

And the group was then growing bigger and bigger because Andreas went to Atlanta, continued to do the courses there. And everybody was going there. He was the only one and it was a lot of fun. The patients were awake, Andreas talked to them, very nice with the patient, you know. He said "Nice belly, nice cook." The patient was waving after the procedure. It was this human atmosphere that you have in the beginning of such a thing, and then it's loosening up and it's getting more routine. And patients are sedated or not part of it anymore, as in the beginning they were part of it.

Q: You mentioned the resistance against the procedure in the beginning. Does that still exist?
There is no resistance, not the resistance we had in the beginning of PTCA. On the contrary, now we have a program for beta radiation. And everybody wants it. Everybody wants to be on the trials. So we have much more response. People want to have something different or new. So it's not like in the beginning.

Q: What about the future of angioplasty?
There is a lot to do, still to do. Carotids, neuroradiology, aortic aneurysm, these are all places we have to do a lot of things. So I don't think it will ever end. There will be always a place to go with ideas. It's a fascinating, absolutely fascinating industry!

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