ANPI Angiotech Pharmaceuticals - Common Shares (MM)

The U.S. 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.

The devices can be used to treat patients with venous thromboembolism, or blood clots in the legs, in order to keep the clot from traveling to the lungs where the clot can be fatal.

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 a unit of 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 the 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.

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 report in the Archives of Internal Medicine looked at two types of Bard filters implanted in patients at York Hospital in York, Pa., after a patient suffered a perforation in the heart three years after receiving an IVC device.

One filter, the Bard Recovery filter, was available from April 2003 through October 2005. It was then modified to reduce the risk of fracture and is sold as the Bard G2 filter.

The study looked at 80 patients who received either device between April 2004 and January 2009. Patients underwent fluoroscopy to look at what happened to the filter, and those whose filters had fragmented underwent additional testing.

Of 28 patients who received the older Bard Recovery filter, seven experienced a filter fracture for a fracture rate of 25%. Among the 52 patients who received the Bard G2 filter, six patients had a fracture for a rate of 12%. While it would seem that the fracture rate for the newer device is half of the old, researchers noted that the average time of implantation and fracture assessment was about 50 months for patients with the older device compared to about 24 months for patients with the newer Bard filter.

Of the six fractures seen with the Bard G2 device, four stayed local to the device implant while one fragment migrated to the lung and in another case a device fragment traveled to the hepatic vein, which drains blood from the liver. Among the seven patients who experienced fractures of the older Bard device, device fragments traveled to the heart in most cases. At least one of the patients had emergency surgery to remove the device fragment, researchers reported.

The FDA said the use of IVC has grown in the past several years. 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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