Pathway Medical, With FDA Clearance in Hand, Starts Selling Device for Wiping Out Blockages in Leg Arteries

9/5/08Follow @xconomy

Pathway Medical Technologies is in the marketing game for real now. The Kirkland, WA-based company has started selling its Jetstream device for clearing out fatty blockages in leg arteries, after winning FDA clearance for a modified version of the device, hiring its initial sales team, and stocking up on inventory for what it expects will be an early wave of demand.

We broke the news first here in July when Pathway won FDA clearance for the Jetstream. The company said then it would take some time before it could hit the market because it wanted to go back to the agency with minor modifications that would make the device easier to manufacture, simpler for doctors to use, and, frankly, look snazzier, says Tom Clement, Pathway’s CEO. The FDA said yes to all the tweaks, Pathway hired a sales staff of 18 to fill out its roster of 150 employees, and it stocked up on several months of inventory.

“We’ve been working feverishly,” Clement says. “We see a very, very bright future for this product and the world of endovascular care.”

Pathway’s Jetstream is a tiny stainless-steel drill mounted on a catheter that snakes inside clogged arteries, where it cuts up and vacuums out fatty buildups. The company is pitching it as the first device capable of drilling into and vacuuming out rock-hard calcium deposits in leg arteries, just as easily as its slices through squishier clots and lesions.

The condition, known formally as peripheral artery disease, affects an estimated 8 million to 12 million people in the U.S., although most go undiagnosed. Besides trying to drum up more demand, Pathway will be competing with Plymouth, MN-based ev3 (NASDAQ: EVVV), maker of a device called the SilverHawk, which cuts and scrapes out buildups. Apparently, the competition is well aware of the threat from Jetstream, and sounds worried. Six sales reps from ev3 have quit their jobs there to come work for Pathway, Clement says. Other ev3 reps are being given bonuses to resist the urge to jump ship to come work at Pathway, he says. “People know this device is coming down the pike,” Clement says.

Despite the excitement at Pathway, Clement says the company is trying to be careful not to commit the sin of getting overzealous. … Next Page »

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  • DR U GOVIND

    What is the smallest calibre of artery that the devise has been used for and what are the results. Is there a centre in South Africa that uses your device?