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."
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.
There’s other good news for Zilver PTX and Cook Medical, he said, as the Centers for Medicare & Medicaid Services approved additional reimbursement for the device.
The Zilver PTX, which won FDA premarket approval in November 2012, was only distributed in the U.S. from Dec. 13, 2012, to April 16, 2013, according to an FDA notice. The device has been cleared on the European market since August 2009 and is approved for sale in 54 countries.
When green-lighted by the FDA, the Zilver PTX was the 1st U.S.-approved drug-eluting stent indicated for treatment of peripheral artery disease. The approval came 1 year after the FDA’s Circulatory Systems Devices Panel unanimously recommended approval for the device, which is a self-expanding drug-eluting stent coated in paclitaxel.
