First Laser-Based Device for IVC Filter Removal Gets FDA Approval

Concept photo: First laser-based device for IVC filter removal approved

The U.S. Food and Drug Administration (FDA) approved the marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The administration announced the IVC filter removal device approval on Monday, December 21st. The device is for patients with an IVC filter.

The filter is a small cage-like device placed into the body’s largest vein to capture blood clots and prevent them from going up the lungs. The new device, the Philips CavaClear Laser Sheath, will help to remove tissue to aid the detachment of an IVC filter during retrieval. The laser-based device is a welcomed improvement as previous IVC filter removal methods failed.

According to Bram Zuckerman, the director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, there have been limited options for the successful removal of chronically embedded IVC filters. He noted they are difficult to remove because of the potential complications associated with the complex procedure.

Zuckerman added that the action by the FDA will provide doctors with an essential tool for the safe removal of IVC filters and potentially help reduce complications in patients. Furthermore, the director said it demonstrates the FDA’s commitment to leveraging real-world evidence where appropriate to evaluate device safety and effectiveness.

Physicians use IVC filters to treat people at risk of a pulmonary embolism. These filters often have FDA approval before being released to the market. However, some IVC filters turned out defective. The defect led to the migration of the device, resulting in other medical complications.

Those who experienced these complications filed lawsuits against the manufacturers. You can do the same if your IVC filter migrated and affected your health. But before doing so, contact a mass tort lawyer to examine your case to determine your eligibility to sue.

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