Forty years after inventing the balloon catheter, Dr. Fogarty reflects on life as an innovator and an oenophile.

By Thomas Fogarty, MD

How did you conceive the idea to create the balloon catheter? When I was working as a scrub technician in high school and college, I got the concept as I observed failed attempts to surgically remove thrombus. I came up with my first design in my senior year of college. During medical school, I built some prototypes using the tip of a No. 5 latex surgical glove and a urethral catheter. Right after my internship, I had time to make the products, cadaver test them, and use them in bench models.

After you developed the device, how did you get it to market? With extreme difficulty. First of all, I was only in training, so I didn’t have any credibility with the manufacturers. Second, they did not yet understand the critical need for the product. The conventional wisdom of the early ‘60s said that if you manipulate the inside of an artery, it will lead to thrombosis. People looked at my product and said, ?You’re crazy. You’re so uninformed that you don’t understand that this will never work.? When the manufacturers asked their ?experts? about the product, the experts relied on what they had been taught, assuming that if you put a balloon in the artery and scraped it, the artery would close. So there was armed resistance to the product’s acceptance—and not just by the manufacturers; I couldn’t get any articles published, either.

My big break was that my mentor, Dr. Jack Cranley, used the product. He was one of the first surgeons to dedicate his entire practice to vascular surgery. Eventually, so many physicians used the catheter based on his recommendation that, like any good technology, it could not be kept back. For the first 2 years, I made each device by hand, but soon I reached the point where I couldn’t keep up with manufacturing while continuing my residency. I was at the University of Oregon at the time with Dr. Albert Starr, who developed the first artificial heart valve. He saw the utility of the catheter and asked an engineer by the name of Lowell Edwards to begin manufacturing it. They developed a start-up company, and I licensed the invention to them.

What skills does a physician doctor-inventor need to have? You need to maintain a questioning spirit. In medicine, we are required to assimilate huge bodies of knowledge during pre-med and medical school, so we don’t have the time or opportunity to challenge basic premises. I think that the educational process knocks the natural intellectual curiosity right out of you. You need to see things not as they are, but as you wish them to be.

Of which invention are you most proud? The balloon catheter, for several reasons. One is that it was the preamble to less-invasive approaches to surgical management. It was also the first endovascular technology that had a definitive therapy as an outcome, and I’m very proud of that. For different reasons, I also take pride in the tissue heart valve concept. At the time I developed it, the high incidence of embolization deterred the use of prosthetic valves. The tissue valve significantly reduced the high incidence and made the concept of valve replacement much more acceptable.

Other than your vineyard, are all of the companies that you have founded in the medical field? Yes. I even consider the vineyard to be a medical company. Wine is a valuable therapeutic drug that prevents cardiovascular disease; it just comes in liquid form. In that respect, I’m involved in preventive medicine. Two glasses of Fogarty Pinot Noir per day is the equivalent of an aspirin and Lipitor.


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