Study: Cordis Corp.’s TrapEase vena cava filter shows high fracture rate

Cordis TrapEase permanent vena cava filter

TrapEase permanent vena cava filter

A new study reported a high fracture rate among permanent inferior vena cava filters made by Cordis Corp., a device-making arm of Johnson & Johnson (NYSE:JNJ).

In a Japanese study of 20 patients with Cordis’ TrapEase IVC filter, the devices fractured in half the patients at 50 months.

The study adds to concerns that surfaced last year when the FDA recommended that physicians consider removing retrievable inferior vena cava filters after logging 921 reports of "adverse events" related to the devices.

The federal watchdog agency warned that certain IVC filters could fracture, causing pieces of the device to travel through the bloodstream to other parts of the body.

Doctors place the device in the inferior vena cava, the main vein that brings blood back to the heart from the lower half of the body, to keep blood clots from traveling to the lungs and causing pulmonary embolisms. The implant treats patients with venous thromboembolism who have not responded to or cannot take anti-clotting medications.

There are two types of IVC filters, a permanent implant and a "retrievable" device meant for temporary use. The FDA said many of the 921 events reported appeared to be related to "a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of [PE] has subsided."

"As dwell times of these devices inside the body increase, the likelihood of device fracture increases," Dr. William Nicholson, who has also conducted research on the matter, told heartwire. "These findings again emphasize that the use of filters, while clearly necessary in some patients, should be used judiciously."

Nicholson added that the potential for fracture is likely not limited to Cordis’ device, but a danger among IVC filters in general.

The filters are made by 10 companies, including units of New Jersey-based C.R. Bard Inc. (NYSE:BCR); Vancouver, B.C.-based Angiotech Pharmaceuticals Inc. (PINK:ANPI); and Conshohocken, Pa.-based Rex Medical LP.

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