Royal Philips announced that the FDA has awarded “Breakthrough Device Designation” to approve a new laser-assisted device for removing IVC Filters that are embedded in a patient’s body.
IVC Filters are wire devices that are implanted in a patient’s vein to catch blood clots and prevent them from reaching the heart or lungs.
In recent years, thousands of lawsuits have been filed by people who were injured when their IVC Filter got stuck, broke, needed multiple surgeries to remove, or caused other serious health issues.
When doctors can’t remove the filter, patients face a lifelong risk of developing severe complications — including sudden death.
The FDA recommends removing IVC Filters as soon as they are no longer needed, but in many cases, doctors are unable to remove it.
As Philips explained, “The failure rate for IVC filter removal is high and limited options for removal exist if the filter has become difficult to remove.” Until now, doctors have had few tools to remove IVC Filters.
Unfortunately, the longer an IVC Filter remains in the body, the higher the risk of long-term complications.
“The filters can fracture and travel through the bloodstream to other parts of the body,” Philips warned. The filters can also become clogged, resulting in major circulatory problems, and even cause blood clots to develop in the lower legs.
Philips estimates that 1 million people in the U.S. with IVC Filters could benefit from having the filter remove to reduce these risks.
“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,” said Atul Gupta, MD, Interventional Radiologist and Chief Medical Officer, at Philips.