名媛直播

FDA approved the Philips CavaClear Laser Sheath for use with conventional snare devices for the removal of inferior vena cava (IVC) filters, the agency on Tuesday.

This makes CavaClear the first device on the market to use a UV laser to remove a small bit of tissue and dislodge the IVC filter when other methods of removal have failed.

"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," said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA Center for Devices and Radiological Health, in a statement.

CavaClear approval was based on a retrospective study of 265 patients that found a 96% procedural technical success rate associated with the laser device. Device-related complications -- counting IVC injury, bleeding, and filter breakage -- reached 3%.

Its approval followed the FDA's de novo pathway and was expedited thanks to Breakthrough Device designation.

IVC filters have been declining in popularity since the FDA's 2010 warning of complications with long-term use. These devices are initially inserted in patients with deep vein thrombosis and pulmonary embolism but can themselves lead to IVC thrombosis if left in the blood vessel.

The latest strongly recommend against use of IVC filters, suggesting their use only in people with acute venous thromboembolism and an absolute contraindication to anticoagulation.

Use of the CavaClear is contraindicated when a blood clot is present within the IVC filter or surrounding veins, when the IVC filter is not accessible, or when the filter is nonmetal. The device should not be used to remove the Bird's Nest and VenaTech IVC filters in particular, FDA warned.

Comment