Dr. Thomas J. "Tom" Fogarty (born on February 25, 1934 in Cincinnati, Ohio) is an American surgeon and medical device inventor. He is best known for the invention of the embolectomy catheter (or balloon catheter), which revolutionised the treatment of blood clots (embolus).
Fogarty was born in Cincinnati, Ohio, on February 25, 1934. His father worked as a railroad engineer, but died when Fogarty was eight years old.
Fogarty cites his father’s absence as being influential in his own creative nature as an inventor. He fixed things that needed to be fixed for his mother, and he worked with soapbox derby cars and model airplanes. "I just had a natural inclination and inquisitive nature about building things. I looked at things and just naturally thought, 'Okay, how can I make this better?'" His business side was evident in childhood as well. The model airplanes that he built were sold to neighborhood kids. When he became frustrated with motor scooter gears, he built and sold a centrifugal clutch.
Fogarty was not a good student, and his original career goal was to be a boxer. “I wasn’t a very good kid. They sent me to a camp to keep me out of trouble. One of the routine activities was boxing."
To help his family get by in the late 1940s, Fogarty started working at Good Samaritan Hospital, beginning with cleaning medical equipment while he was in the eighth grade at school. He continued working during his high school summer vacations and was soon promoted to scrub technician, a person who handed medical instruments to surgeons – he witnessed his first surgery at a young age. It was during this time that he first met Dr. Jack Cranley, who would have a major influence on Fogarty's future career.
During his last year of high school, Fogarty discovered that he wanted to be a doctor. At the age of 17, he quit his boxing career after he broke his nose in a match that ended in a draw. A family priest gave him a recommendation, and because of his awful grades, he was admitted to Cincinnati’s Xavier University on probation. Jack Cranley, one of the most prominent vascular surgeons in the United States became his mentor. Speaking of Cranley, Fogarty later stated: “I had a mentor who encouraged me and helped to persuade me to go to college… He had 10 kids and I became the 11th. He always told me, ‘You are smarter than you think.’”
Fogarty graduated from Xavier University with a bachelor’s degree in biology in 1956 and went on to attend the University of Cincinnati College of Medicine, where he graduated summa cum laude in 1960. From 1960 to 1961, he interned at the University of Oregon Medical School in Portland, Oregon, and he completed his surgical residency at the same school in 1965.
During Fogarty’s years at Good Samaritan Hospital, he witnessed the deaths of many patients who died from complications in blood clot surgeries in their limbs. “Fifty percent of the patients died. I thought there must be a better way.” Before Fogarty’s invention, surgeons had to use forceps to remove the blood clots only after a huge part of an artery had been cut open, and the patient would be under general anesthesia for hours. Blood flow is usually interrupted in the procedure, increasing the risk of the patient losing a limb.
At home, the ideas that went through Fogarty’s head concerned different ways of making the procedure better, and he especially concentrated on avoiding the risky incisions. He tinkered with a urethral catheter and a balloon in his attic. Because a catheter only required a small incision, it would be able to get to the clot without much trauma to the patient. The urethral catheter is also flexible yet strong enough to be pushed through a blood clot. As for the balloon, he basically cut off the tip of the pinky finger of a size 5 surgical latex glove and attempted to incorporate it onto the end of the catheter. The resulting balloon could be inflated with saline using a syringe, and once it expands to the size of the artery, it is then retracted, withdrawing the clot through the artery and out the incision.
The main problem in building this device was the way the balloon could be attached to the catheter. Glue that could hold vinyl, the material making up a catheter, and latex, the type of glove used, was not available. Fogarty’s own take on the catheter came about because of fishing techniques he learned as a child. Precise hand-tying was needed in fishing, and with these techniques, he tied the balloon to the catheter. "I'd always tied flies and made lures so it was just a natural thing." His experimental balloon catheter, however, always seemed to burst when it was over inflated. It even broke when he dragged it through glass tubes filled with Jell-o, a model he thought simulated a clot within an artery. After some time, he figured out the type and thickness of rubber that was firm enough when inflated to extract a clot and still flexible enough to move through without breaking. The device, made before Fogarty even received his MD from University of Cincinnati in 1960, became the first minimally invasive surgical device.
Fogarty, however, came across difficulties in getting a manufacturer to produce it. From 1959 to 1961, nobody was willing to help. "Companies thought I was some stooge fooling around. I didn't have any credibility." Dr. Cranley continued to encourage him, and soon, during his fellowship training at the University of Cincinnati in 1961 and 1962, Fogarty started to make the catheter system by hand for himself and for other vascular surgeons.
At the University of Oregon, while Fogarty was completing his residency in surgery, Dr. Al Starr, head of the cardiothoracic division, used Fogarty’s balloon catheters. After he was informed that no company was willing to manufacture Fogarty’s device, he asked one of his acquaintances, Lowell Edwards, an electrical engineer and president of his own company, to give the device consideration in producing it. In 1969, Fogarty patented his device, and Edwards Life Sciences from Irvine, California, was assigned the patent to begin manufacturing the Fogarty embolectomy catheter.
Because of the decreased risk associated with the device, Fogarty's balloon catheter became the industry standard and remains the most widely used catheter for blood-clot removal. Before his invention the success rate for removing an embolus, or blood clot, was forty to fifty percent. The balloon catheter is now used in over three hundred thousand procedures every year all over the world, and is estimated to have saved the lives and limbs of approximately twenty million patients.
Numerous sequel applications of Fogarty’s catheter came about. The first balloon angioplasty, for example, was performed with a Fogarty catheter in 1965, and has led to over six hundred fifty thousand such operations per year. Fogarty has also modified his catheter to less invasive biopsy techniques.
After completing his residency and becoming a cardiovascular surgeon, Fogarty continued to invent new medical devices. One of his most successful products is the Stent-Graft, which dealt with the difficult problem of abdominal aortic aneurysms (a term referring to a weakened blood vessel). The old method was to remove the bad part of a weakened blood vessel, but Fogarty’s idea was to support it with an implant. He used a stent, a thin polyester tube that grabs onto the blood vessels. A catheter transports the stent to the weakened blood vessel, and once the balloon is inflated, the stent expands to the size of the blood vessel, and blood flows normally.
Fogarty's other inventions include Fogarty surgical clips and clamps, which are used by cardiac and vascular surgeons to temporarily occlude vessels during surgery. Working with Warren Hancock, he is co-inventor of the Hancock tissue heart valve – the world's first porcine valve.
Fogarty’s own inventions and the many others that resulted from his original embolectomy catheter heavily influenced the way surgery was performed. Considered one of the pioneers of minimally-invasive surgery, Fogarty has said: "I had no concept that [non-invasive surgery] would reach the magnitude that it has."
As a result of the embolectomy catheter and other inventions, Dr. Fogarty has won many prizes, including the National Medal for Technology and Innovation in 2012, and a Lifetime Achievement Award from the Advanced Medical Technology Association (AdvaMed) in 2015. He has published around 180 scientific articles and textbook chapters in the fields of general and cardiovascular surgery. He served as President of the Society for Vascular Surgery from 1995-1996.
Fogarty founded Fogarty Engineering, Inc. in 1980, to promote ideas for new medical devices, and has founded/co-founded and chaired the board for many business and research companies based on devices developed at the company.
In 1993, with Mark Wan and Wilfred Jaeger, he founded Three Arch Partners, a venture capital fund to invest in new technology and medical devices. Three Arch helped to create and fund more than 100 companies.
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