FDA Advisory Committee Gives Thumbs-Up to Abbott's MitraClip

An FDA advisory committee has voted that the benefits outweigh the risks for Abbott’s (NYSE: ABT  ) MitraClip device in treating mitral regurgitation patients at too high a risk for open mitral valve surgery. The mitral valve is in the heart.

The committee voted with five positive opinions and three negative ones, according to an Abbott press release, and the committee voted in favor of the device’s safety profile without a single negative opinion, although the panel was mixed when voting over MitraClip’s reasonable assurance of efficacy, with four saying "yes" and five saying "no."

The MitraClip device is designed to treat mitral regurgitation, the most common form of heart valve insufficiency, according to Abbott. The ailment causes blood to flow back through the mitral valve and into the heart’s left atrium, a condition that can ultimately lead to severe or even fatal problems such as heart attack or stroke.

Abbott’s MitraClip gained CE Mark approval in Europe in 2008 and is commercially available in numerous international markets already. The company’s still trying to gain approval from the FDA in the U.S., but the advisory committte’s recommendation should help the decision, which the company expects later this year.


Read/Post Comments (0) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2327585, ~/Articles/ArticleHandler.aspx, 9/28/2016 1:42:15 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 4 hours ago Sponsored by:
DOW 18,228.30 133.47 0.74%
S&P 500 2,159.93 13.83 0.64%
NASD 5,305.71 48.22 0.92%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

9/27/2016 4:02 PM
ABT $42.33 Up +0.65 +1.56%
Abbott Laboratorie… CAPS Rating: *****