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Outlook for Abbott DES Approval Is Good
An FDA staff report recommends approval of Abbott's Xience drug-eluting stent, saying that it is safer than existing devices, reports Bloomberg News. The report comes in advance of this week's Circulatory System Devices Advisory Panel meeting.
November 28, 2007
1 Min Read
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If the panel agrees with the staff, chances for approval become very high.The report said that over two years, patients with Xience were half as likely to die, suffer a heart attack, or need repeat surgery than patients with Boston Scientific's Taxus. It also advocated longer studies after approval to ensure the device does not cause blood clots over time. This is no surprise; post-approval studies of Class III devices are almost de rigeur by this point.UPDATE: On Thursday night Nov. 29, the advisory panel did indeed recommend Xience for approval.
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