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Cook Zilver Peripheral Stent wins PMDA approval

The Pharmaceuticals and Medical Devices Agency (PMDA) has approved Cook Medical to sell its Zilver PTX Drug-Eluting Peripheral Stent in Japan.

The Zilver Stent is designed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA).

The Stent also facilitates physicians treating PAD in SFA, with the combination of mechanical support via stenting with the drug paclitaxel to reduce the risk of restenosis.

Cook Medical peripheral intervention division vice president and global leader Rob Lyles said the Zilver peripheral stent represents progress in treating PAD, and the Japanese government should be proud of the commitment it has shown to patients with this timely approval.

"Clinical trials show that Zilver PTX has better long-term patency outcomes than bare-metal stents," Lyles added.

The company said the Zilver Stent is under US Food and Drug Administration (FDA) review and is not available for sale in the US.