Laser-assisted IVC filter removal device nets FDA breakthrough designation
Royal Philips announced the FDA has granted breakthrough device designation for its laser-assisted inferior vena cava filter removal device.
According to a company press release, the device is intended for ablating tissue to remove an IVC filter when previous attempts at removal failed.
Breakthrough devices receive priority FDA review; the designation allows early interaction with FDA personnel to expedite the review and approval process.
According to the release, filters are used to treat patients with venous thromboembolism and are placed in the IVC to prevent blood clots from moving to the heart or lungs.
The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated, according to the release. Filters can fracture and travel through the bloodstream to other parts of the body; cause lower limb deep vein thrombosis; and IVC occlusion. However, the failure rate for filter removal is high and limited removal options exist if the filter has become difficult to remove.
“There is a clear need for an innovative device to help physicians more safely perform advanced IVC filter removal and I believe that the Philips excimer laser sheath may greatly enhance the options available to succeed in filter retrieval,” Atul Gupta, MD, an interventional radiologist and chief medical officer of image-guided therapy at Philips, said in the release. “Breakthrough device designation is an important step for a medical innovation such as this one to help fill an unmet need in patient care.”