08.04.15
South Jordan, Utah-based Merit Medical Systems Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) expanding indication for its 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, according to the Centers for Disease Control and the World Health Organization. QuadraSphere Microspheres are calibrated and designed to offer controlled, targeted embolization, treating HCC by stopping the blood flow to the tumors.
“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.”
Merit Medical Systems makes disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.
“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.”
Merit Medical Systems makes disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.