Pathway Wins FDA Approval To Sell Blocked-Artery Buster

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Christmas has come in July for Pathway Medical Technologies. Theprivately-held maker of medical devices in Kirkland, WA, has wonFDA approval to market its first product in the U.S., a drill thatcuts and vacuums out blockages in leg arteries.
CEO Tom Clement had an antsy look on his face last Wednesday, likea kid waiting for Christmas morning. “We’re so close, Ican taste it,” he said on a visit to his office. The FDAapproval letter arrived two days later, Xconomy has learned.
It’s a remarkable turnaround story. Pathway ran out of cashand literally closed its doors in November 2004. It was re-bornfour months later when it stopped trying to treat the heart, andswitched its focus to a less crowded market of companies that treatthe legs. Pathway’s device, the Jetstream Atherectomy System,works the same way in either part of the anatomy. It’s a tinystainless-steel drill mounted on a catheter that snakes insideclogged arteries, where it cuts up and vacuums out fatty buildups.
The approval means Pathway can now market its device specificallyto doctors who treat peripheral artery disease. An estimated 8 to12 million people in the fast-food loving U.S. have blockages inthe 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 medicaltechnology in the country, much less just here in theregion,” says David Auth, a director of Pathway and theformer CEO of Heart Technology, a Redmond, WA-based company thatdeveloped a previous-generation device in the 1990s for drillingout heart blockages. The market for such a device? It “couldeasily top $150 million in annual sales,” Auth says.“If they execute well, they will easily top $200million.”
Pathway’s FDA application was based on a study of 172patients in Europe, which found that its device sliced throughrock-hard calcium and squishier blockages without tearing or pokingany holes in vessel walls. Three patients developed clots or debristhat required treatment, which contributed to a serious adverseevent rate of 2.9 percent. The effectiveness was eye-opening.Arteries of patients went from 89 percent blocked on average at thebeginning of the study to 39 percent clogged after the Pathwaydevice was used, according to data presented in October at theTranscatheter Cardiovascular Therapeutics conference in WashingtonD.C.
The arteries apparently stay open, too. After six months offollow-up, only about 14 percent of patients required a secondprocedure, Clement says, compared with about half of patients aftertraditional balloon angioplasty.