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Cook receives FDA Advisory Committee recommendation for Zilver DES

Cook Medical has received an unanimous recommendation from the US Food and Drug Administration's (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee for its Zilver PTX drug-eluting stent (DES).

The Circulatory System Devices panel said it will recommend approval of the device on the basis of its safety, efficacy and acceptable risk profile.

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

Cook Medical peripheral intervention unit vice president and global leader Rob Lyles said the company will await a final decision on approval to market this device in the US from the FDA in the coming months.