Merit Medical has announced that it has received 510(k) clearance from the US FDA expanding indication for QuadraSphere microspheres to include the embolization of hepatoma.
Malignant hepatoma, also known as hepatocellular carcinoma (HCC), is the sixth most common cancer and the third leading cause of cancer deaths worldwide. QuadraSphere Microspheres are precisely calibrated and designed to offer controlled, targeted embolization, treating HCC by stopping the blood flow to the tumours.
“The FDA’s clearance of QuadraSphere for the embolization of hepatoma provides another treatment option for patients and physicians in their battle against primary liver cancer,” said Fred Lampropoulos, Merit’s chairman and CEO. “This clearance also represents a milestone in our continual efforts to improve patients’ lives through the development of innovative technologies that produce better patient outcomes.”