Product News and Recalls

FDA approves new heart filter

According to a report on TheHeart.org, the U.S. Food and Drug Administration (FDA) has approved a new vena cava filter made by Crux Biomedical of California.

The company is touting the new device as a safer alternative to earlier models, which have been prone to potentially deadly fracturing.

The heart processes blood — removing carbon dioxide and adding oxygen from the lungs. The oxygen-poor blood enters the heart through two main veins called the superior vena cava (SVC) and the inferior vena cava (IVC).

A blood clot can travel to the lungs through the IVC, resulting in a very serious condition called pulmonary embolism. One method doctors use to prevent the condition is implanting a filter that catches and stops blood clots.

But a study conducted by the New England Society for Vascular Surgery noted a 31 percent fracture rate in IVC filters. Most of the broken filter shards ended up in patients’ right ventricles of the heart, with potentially deadly consequences.

Bard Peripheral Vascular, manufacturer of Recovery IVC Filters, allegedly knew of these risks, but concealed them from patients and the U.S. Food and Drug Administration.

The report from TheHeart.org says vena cava filters are supposed to be implanted temporarily, but many are never retrieved.

While most other filters have a trapezoidal tent shape, the newly approved model has a figure-eight design that’s supposed to make it easier to remove.

If you’ve received an IVC filter, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a IVC filter lawyer to discuss your legal rights.

See the report here:

http://www.theheart.org/article/1427517.do