FDA Warns About Long-Term Problems With Blood-Clot Device

Date : 08/09/2010 @ 3:22PM
Source : Dow Jones News
Stock : C.R. Bard, Inc. (BCR)
Quote : 307.75  0.2 (0.07%) @ 11:09AM

FDA Warns About Long-Term Problems With Blood-Clot Device

Johnson & Johnson (NYSE:JNJ)
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The Food and Drug Administration warned Monday that certain devices used to keep blood clots from traveling to the lungs could fracture and migrate to other parts of the body.

Known as inferior vena cava, or IVC, filters, the small devices are inserted into the main vessel returning blood from the lower half of the body.

Since 2005, the FDA said it has received 921 adverse event reports associated with the devices, which are made by 10 companies including a unit of Johnson & Johnson (JNJ), Angiotech Pharmaceuticals Inc. (ANPI) and C. R. Bard Inc. (BCR). The reports included device migration, or moving within the body; detachment of device parts; filter fracture and perforation of the inferior vena cava.

The FDA didn't detail the number of reports by manufacturer. However, a separate report published online Monday in Archives of Internal Medicine found some problems associated with two types of filters made by C.R. Bard. A spokesman for C.R. Bard didn't immediately return a request for comment.

The FDA said many of the adverse events appeared to be related to a retrievable filter left in the body for long periods of time. The agency said doctors should remove the filter once the risk of pulmonary embolism, or a blood clot in the lungs, has passed. A pulmonary embolism can be fatal.

There are two types of IVC devices: one meant to be permanently implanted in the body and a so-called retrievable device meant for temporary use. The devices are used in patients who can't take or don't respond to anticlotting medications.

"The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides," the agency said in a statement posted to its website Monday.

The FDA cited industry figures showing growing use of IVC filters in the past three decades. In 2007 about 167,000 filters were implanted with projections of 259,000 implantations by 2012.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

 
 

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