Cook's Zilver stent recall could be a costly one

Cook Medical's ongoing recall of its Zilver PTX stent could be a costly one. While the company isn't commenting on how many stents it has recalled since the FDA slapped its most serious "Class I" status on the effort late last month, the product has been deployed in more than 30,000 patients internationally since its 2009 overseas approval, according to company data cited by The Indianapolis Business Journal. The article also notes Millennium Research Group estimates that point to the stent generating $2,750 per U.S. sale. Zilver just gained U.S. approval last November. Millennium estimates Zilver could sell 40,000 units annually just in the U.S., producing $100 million in annual revenue. It is the first drug-eluting stent cleared in the U.S. to treat peripheral artery disease. Story

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