Bloomington-based Cook Medical has won European approval for a new artery-opening device for the legs that it predicts
will be a blockbuster.
The device, called the Zilver PTX, is a flexible metal stent that holds open collapsed arteries and is coated with a drug to prevent the artery from growing shut again. It is the first drug-coated stent designed for legs approved in the world.
Clinical trials using the device showed that it improved two-year success rates from 70 percent (using stents with no drug coating) to 87 percent. The device, implanted using a minimally invasive catheter, has even better success rates than open surgery.
"This is really emerging as best in class," said Rob Lyles, vice president of the peripheral intervention unit of Cook Medical. "That's why this has the potential to be such a blockbuster for us."
Cook estimates that the Zilver PTX could help it grab 50 percent of the European market, which is about $200 million a year. Cook also hopes to win U.S. approval, where the annual market tops $3 billion.
Collapsing of a leg artery, known as peripheral artery disease, affects 27 million people in Europe and North America.
The worldwide market for leg stents is projected to triple in the next seven years, Lyles said, right along with the incidence of diabetes and obesity and the aging of the baby boomers.
Those same conditions are driving up the rate of artery-opening devices around patients' hearts. Drug-coated stents to prop open arteries around the heart have been available for several years.
"That cheeseburger you ate didn't just go to your heart," Lyles said. "If you have problems in the arteries of your heart, somebody better be checking your legs."