Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. Here is a link to the FDA and Edwards briefing documents.
6:00– The committee votes 10-2 that Sapien is safe, 12-0 that it is effective, and 11-0 (1 abstention) that the benefits outweigh the risks.
5:55– Here’s questions 2 and 3:
VOTING QUESTION 2: Is there reasonable assurance that the Edwards SAPIENTM Transcatheter Heart Valve is effective for use in patients who meet the criteria specified in the proposed indication?
VOTING QUESTION 3: Do the benefits of the Edwards SAPIENTM Transcatheter Heart Valve for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication?
5:54– Wow– computer voting system is broken! They’re going to vote on paper.
5:48– After they finish the legal mumbo jumbo the voting will begin.
5:43– Getting close to the voting questions. Here’s #1:
VOTING QUESTION 1: Is there reasonable assurance that the Edwards SAPIENTM Transcatheter Heart Valve is safe for use in patients who meet the criteria specified in the proposed indication?
5:39– Edwards via Craig Smith giving their summary. He says he’ll be brief.
5:38– Now talking about study data that should be included in the labeling.
5:30– Now talking about post-approval studies to get further insights into stroke, aortic regurgitation, long term effectiveness, valve-in-valve, and gender issues.
5:28– Now discussing the totality of the evidence. Chairman states that the committee agrees that Sapien is safe and effective, with a number of caveats, such as stroke, TA/TF, gender, AR. (Why bother voting now?)
5:20– Committee now discussing informed consent and whether a more detailed informed consent form should be required. An additional piece of paper is not really the ideal solution.
5:15– Chairman summarizes that the FDA is concerned that valve-in-valve use may occur, but there’s no data to support this. Committee strongly encourages getting data on this and it should not be endorsed on the label. Committee wants to motivate the company to perform a separate clinical trial for this indication.
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