Zilver PTX Recommended for FDA Approval in a Unanimous Vote from the Medical Devices Advisory Committee, According to Millennium Research Group
TORONTO--(BUSINESS WIRE)-- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, Cook Medical’s Zilver PTX drug-eluting stent is likely to be approved for use in the United States and launch in the first quarter of 2012. Last week, the Food and Drug Administration’s (FDA) Medical Devices Advisory Committee recommended Cook Medical’s Zilver PTX Drug-Eluting Stent for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). Zilver PTX would be the first drug-eluting stent in the US indicated for the treatment of PAD in the SFA. According to proprietary MRG analysis, treatment of PAD in the femoropopliteal arteries will grow 12 percent per year through 2015, reaching 250,000 stent procedures annually.
Currently, PAD is treated in the US either through balloon angioplasty, bare metal stenting or atherectomy. Zilver PTX results show a higher rate of patency (ability to keep vessels open) than PTA balloons or bare metal stents, at both one year and two year trial results. According to Cook Medical, Zilver PTX is currently sold in 48 countries.
“Right now, Cook Medical has about five percent of the US peripheral vascular stent market,” said MRG Principal Analyst Karene Dumoulin. “We forecast unit sales of 15,000 to 17,000 units for Zilver PTX in the first year of launch, rising to as many as 40,000 units in 2015. If we assume a slight price premium over covered stents, this could represent $110 million in sales in 2015, giving Cook 10 percent of the peripheral vascular stent market. This would represent substantial growth for Cook.”
Leading manufacturers of peripheral vascular stents include Cordis, which recently announced it will leave the coronary drug-eluting stent market, Boston Scientific and Abbott Laboratories. Together the top three manufacturers account for more than half of the PV stent market.
Millennium Research Group has reports that cover every aspect of this market worldwide, including:
- US Markets for Peripheral Vascular Devices
- European Markets for Peripheral Vascular Devices
- Japanese Markets for Peripheral Vascular Devices
- Asia Pacific Markets for Peripheral Vascular Devices
- Latin American Markets for Peripheral Vascular Devices
- Canadian Markets for Peripheral Vascular Devices
About Millennium Research Group
Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.
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