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FDA Approves Laser-Assisted IVC Filter Removal for Filter Fractures, Migration and Vessel Wall Perforations

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

On December 21st, the FDA approved the Philips CavaClear Laser Sheath for use with conventional snare devices for the removal of inferior vena cava (IFC) filters. CavaClear is the first device available on the market to use UV lasers to remove small pieces of tissue and successfully dislodge IVC filters. This is a needed procedure for the many complications which have been occurring and frustrating interventional radiologists.

Philips stated that CavaClear uses circumferential tissue ablation that is able to capture the filter within seconds of laser activation. This helps increase physicians’ efficiency during removal, which consequently lowers costs by reducing the number of retrieval attempts needed to remove an embedded filter.

Dr. Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA Center for Devices and Radiological Health, stated “To date, there have been limited options for the successful removal of chronically embedded IVC filters, as they can be difficult to retrieve due to potential complications associated with the complex procedure,”

CavaClear was approved based on a study of 265 patients that resulted in a 96% procedural success rate. Device-related complications such as IVC injury, bleeding, and filter breakage were recorded in only 3% of procedures.

IVC filters have been declining in popularity since the FDA warned users of risks associated with long-term use in 2010. These devices are inserted in order to aid patients with deep vein thrombosis and pulmonary embolisms, however, the devices themselves can lead to IVC thrombosis if left in the blood vessel.

If you or someone you know has suffered from complications of an IVC filter, contact the New York product liability lawyers at Rheingold Giuffra Ruffo Plotkin & Hellman LLP for help exploring your legal options. We are aggressively pursuing litigation in various courts around the United States.

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