Royal Philips (NYSE:PHG) announced today that it received FDA breakthrough device designation for its laser-assisted IVC filter removal device.
Amsterdam-based Philips designed its laser-assisted inferior vena cava (IVC) filter removal device to ablate tissue to remove an IVC filter when previous methods of removal have failed, according to a news release.
IVC filters are used for the treatment of venous thromboembolism, with placement in the inferior vena cava to capture blood clots from moving to the heart or lungs. Such filters can have long-term complications, so the FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.
According to Philips, the failure rate for such removal is high and limited options exist if the filter becomes difficult to remove. Dr. Kush R. Desai — associate professor of radiology, surgery & medicine & director of deep venous interventions at Northwestern University’s Feinberg School of Medicine — said in the release that the FDA breakthrough nod “reflects the potential impact” Philips’ IVC filter removal technology could have.
“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,” Philips CMO of image-guided therapy Dr. Atul Gupta 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 inpatient care.”