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A Few Beats Ahead: Medical Device Pioneers


 

By Doug Brunk, San Diego Bureau

Dr. Thomas J. Fogarty was a 4th-year student at the University of Cincinnati in 1960 when he invented the balloon embolectomy catheter, a device that would eventually transform vascular surgery.

But initial acceptance was slow. Three major medical journals refused to publish a paper he assembled about the device because "it was contrary to all accepted concepts about vascular surgery," Dr. Fogarty recalled in an interview. "It was taught that if you touched the inside of the vessel, even with a forceps, it would immediately thrombose. I was scraping the inside of an artery with a balloon."

He also suspects that part of the initial lukewarm reception had to do with the fact that, at the time, he was in his mid-20s. When he arrived at medical meetings as an invited guest to speak about the balloon embolectomy catheter "I'd show up and they wouldn't believe that I was the individual that was responsible for it," he said. "They would ask, 'Are you sure you're Dr. Fogarty?'"

Dr. Fogarty credits his early success to Dr. Jack Cranley, one of the first surgeons in the country to devote his practice to vascular surgery. The two met when Dr. Fogarty was a high school student working as an orderly at Good Samaritan Hospital in Cincinnati. "My father died when I was very young," Dr. Fogarty said. Dr. Cranley "became my father figure and encouraged me. I worked for him doing various jobs, from mowing his lawn to painting stripes in the [hospital] parking lot."

He eventually became Dr. Cranley's scrub technician in the OR, where the two realized that the surgical technique and instrumentation used to remove a blood clot from occluded arteries in the extremities was inadequate. Dr. Cranley turned to Dr. Fogarty and said, "Tom, you can fix this."

Under Dr. Cranley's mentorship during medical school, Dr. Fogarty designed a balloon catheter and performed experiments in animals and cadavers to perfect the device.

At that time, "there weren't many materials that were medical grade," he said. "The ones that existed [were part of] conventional systems, like a ureteral cathether. I took materials that were available and made the catheter system."

Today, he holds more than 63 patents for surgical instruments, including the AneuRx stent graft, and runs his own engineering company that develops medical devices. He also owns a winery in Woodside, Calif., and teaches surgery at Stanford (Calif.) University, where he served as medical staff president from 1970 to 1979.

A married father of four grown children, Dr. Fogarty said that balancing family with clinical work and the development of medical inventions early in his career was difficult. "If you take on that kind of challenge, you have to spend a lot of time," he said. "Retrospectively, I regret the fact that I didn't spend more time with the family. When you're so dedicated and focused on what you're doing and you love to do it, sometimes you put the family in second place. I am regretful that I did that, but things turned out fine. My kids are doing well."

Inspired by Mentors

Dr. Robert A. Levine found inspiration to pursue work in medical inventions from a pair of mentors. One was Dr. Solomon Berson, an internist who in 1968 became the chair of medicine at Mount Sinai Hospital in New York. The other was Rosalyn S. Yalow, Ph.D., a physicist with whom Dr. Berson developed the radioimmunoassay. Dr. Yalow was awarded the Nobel Prize in physiology/medicine for this achievement after Dr. Berson's death.

"Dr. Berson inspired me to practice both medicine and science," said Dr. Levine, an endocrinologist and clinical professor of laboratory medicine at Yale University, New Haven, Conn. "Dr. Yalow inspired me with her determination, intellect, and professionalism."

In the mid-1970s, Dr. Levine had a busy internal medicine practice 15 miles from New Haven but was frustrated by the time it took to get results from his patients' simple blood tests. "These were patients who came in without appointments [for] a bad cough, possible pneumonia, a stiff neck to rule out meningitis, or a little bit of blood in their stool," Dr. Levine recalled. "I didn't want to wait 24 hours to get the results back from the laboratory."

He and Dr. Stephen C. Wardlaw, also a clinical professor of laboratory medicine at Yale, developed an in-office instrument that performs a complete blood count in about 5 minutes. They patented the device and licensed it to Becton Dickinson and Co. when they were in their early 30s. The device, currently known as the QBC Star Centrifugal Hematology System, marked the beginning of an invention partnership that has spanned nearly 3 decades.

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