Currents

This Month

Research

Students Say

Home

Archives





      James Joye, D.O.  OU-COM '88

 




This story originally appeared in the Winter 2003 edition of Ohio Today

Behind a breakthrough

Physician develops new method for treating vascular disease

By Jennifer Kirksey Smith

     James Joye’s invention of a new medical device to treat vascular disease has taken him from a pig farm in Northern California to operating rooms all over the world.
     Joye, DO ’88, pitched his idea to use a liquid nitrous oxide-filled balloon to open blood vessels to catheter engineer Ronald Williams over dinner more than five years ago.
     “It’s not the craziest thing I ever heard,” Williams told Joye.
     And on that leap of faith, the two men pooled their resources to create CryoVascular Systems Inc. Williams, who has 20 years’ experience with medical start-up companies, converted his California garage into a venue for building prototypes of the device, and Joye tested it. Their efforts created the PolarCath Peripheral CryoPlasty System, a medical device that treats clogged leg arteries using a new form of balloon angioplasty. 
     CryoPlasty is being clinically evaluated to treat peripheral vascular disease, a condition in which leg arteries become blocked by plaque. More than 10 million people in the United States alone are thought to suffer from the disease.
     When the disease is treated by conventional balloon angioplasty, a small balloon at the tip of a catheter is placed in a vessel at the site of a blockage. Saline is used to expand the balloon, compressing the plaque that lines the wall of a clogged artery and opening the vessel for better blood flow. But this also can traumatize the vessel wall, producing scar tissue.
     CryoPlasty is similar to conventional angioplasty, but it uses pressurized liquid nitrous oxide instead of saline to inflate the balloon. Cooling the vessel while dilating is gentler on the artery than conventional angioplasty and may even prevent reclogging, Joye says.
     Creating a device using this technology began with many different medical trials, including one at a pig farm and animal research facility in Northern California. Joye and Williams spent two and a half days there performing initial experiments with the device.
     These trials allowed them to create a slick medical instrument and perfect the procedure, which they decided to test first in Europe, where Joye obtained the CE Marking, similar to U.S. Food and Drug Administration approval. In order to meet the regulations of various European countries, Joye has performed minitrials in Germany, Austria, Greece, France, Romania and Italy. 
     Physicians at the May 2002 Paris Course on Revascularization, a top European conference showcasing new medical techniques and technology, viewed live satellite feeds as three operations incorporating the device were in progress in Germany. Among news outlets that carried information on the advance were CNN.com, WebMD and In Vivo, a global healthcare trade publication.
     “There you are live via satellite to several thousand doctors all over the world,” Joye says. “Suddenly the medical community doesn’t seem so big. The world becomes a smaller, friendlier place.”
     The device received approval from the FDA in September. A launch in the United States is set for this spring at a small number of hospital sites around the country. 
     “This is something that I wish all doctors could go through, the beginning-to-end experience of creating something like this to understand what it takes to make a drug or medical device,” says Joye. “It is a roller coaster of emotion and milestones. It is really brutal. I might be smiles and giggles now, but I remember the lows when, for example, the device didn’t work.”
     CryoVascular Systems, the privately held Silicon Valley start-up company Joye helped found, focuses on state-of-the-art interventional therapy for vascular disease treatment and also is testing a similar device for the treatment of coronary artery disease.
     It has been a task to juggle the medical trials with his medical practice and life with his wife, Carolyn, and their two children, Kyle and Casey, in Monte Sereno, Calif. But what resonated with him during medical school was not only the passion his instructors had for medicine but the priority they placed on family. 
     “I try not to lose sight of what’s important,” Joye says. “I am passionate about medicine, but family comes first. That is something I learned at OU.”
Jennifer Kirksey Smith is a writer for University Communications and Marketing.