Pathway Wins FDA Approval To Sell Blocked-Artery Buster
Christmas has come in July for Pathway Medical Technologies. The privately-held maker of medical devices in Kirkland, WA, has won FDA approval to market its first product in the U.S., a drill that cuts and vacuums out blockages in leg arteries.
CEO Tom Clement had an antsy look on his face last Wednesday, like a kid waiting for Christmas morning. “We’re so close, I can taste it,” he said on a visit to his office. The FDA approval letter arrived two days later, Xconomy has learned.
It’s a remarkable turnaround story. Pathway ran out of cash and literally closed its doors in November 2004. It was re-born four months later when it stopped trying to treat the heart, and switched its focus to a less crowded market of companies that treat the legs. Pathway’s device, the Jetstream Atherectomy System, works the same way in either part of the anatomy. It’s a tiny stainless-steel drill mounted on a catheter that snakes inside clogged arteries, where it cuts up and vacuums out fatty buildups.
The approval means Pathway can now market its device specifically to doctors who treat peripheral artery disease. An estimated 8 to 12 million people in the fast-food loving U.S. have blockages in the legs, and about one-fourth have sought some sort of treatment, complaining of pain when they walk.
“This is one of the most exciting companies in medical technology in the country, much less just here in the region,” says David Auth, a director of Pathway and the former CEO of Heart Technology, a Redmond, WA-based company that developed a previous-generation device in the 1990s for drilling out heart blockages. The market for such a device? It “could easily top $150 million in annual sales,” Auth says. “If they execute well, they will easily top $200 million.”
Pathway’s FDA application was based on a study of 172 patients in Europe, which found that its device sliced through rock-hard calcium and squishier blockages without tearing or poking any holes in vessel walls. Three patients developed clots or debris that required treatment, which contributed to a serious adverse event rate of 2.9 percent. The effectiveness was eye-opening. Arteries of patients went from 89 percent blocked on average at the beginning of the study to 39 percent clogged after the Pathway device was used, according to data presented in October at the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.
The arteries apparently stay open, too. After six months of follow-up, only about 14 percent of patients required a second procedure, Clement says, compared with about half of patients after traditional balloon angioplasty.
Pathway doesn’t plan to begin selling its device immediately, however. The company first needs … Next Page »