Cook Medical gets its Zilver PTX back on the market

August 7, 2013 by Brad Perriello

Cook Medical says its Zilver PTX peripheral stent, which it recalled back in April, is back on the market worldwide.

Cook Medical gets its Zilver PTX back on the market

Three months after the recall of its Zilver PTX peripheral stent, Cook Medical has the device back on the market across the globe.

Rob Lyles, vice president and global leader of Cook’s peripheral intervention business, told MassDevice.com today that the FDA cleared the device to go back on the U.S. market July 25.

"We had already received similar clearances in Europe and Japan," Lyles told us, noting that Australia also OK'd the return to market July 25. "We had received regulatory clearance globally in all the major markets as of the 25th, so late last week we began shipping product back out."

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Back in April, Cook recalled all sizes, diameters and lot numbers of the Zilver PTX drug-eluting stent after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. It took about 90 days to correct the issue and to make sure there was enough inventory on hand to meet demand, Lyles said.

"We've obviously been working very hard, interactively with the regulatory folks, but also on the operational side to make sure we had product available when the time came," he said. "In terms of being able to supply existing Zilver PTX customers, we have supply to be able to do that."

There are still some "milestones" to be resolved with the FDA, Lyles added, saying he expects those to be put to rest over the next 60 days or so.

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