FDA Approves Merit Medical's HiQuality Clinical Trial Protocol For The Treatment Of Primary Liver Cancer

First large-scale multi-site U.S. study comparing doxorubicin-eluting QuadraSphere™ Microspheres to conventional chemoembolization

Interventional radiologists from U.S., Europe, South America participating in liver cancer study

SOUTH JORDAN, Utah, Nov. 29, 2010 (GLOBE NEWSWIRE) -- The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s (Nasdaq:MMSI) phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere ^™ Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.  The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.

QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations.  The identical product marketed in Europe as HepaSphere Microspheres ^™ has been CE-marked in the European Union since 2007 for embolization of HCC and hepatic metastases, with or without delivery of doxorubicin.  

"I am extremely pleased with the efforts of our BioSphere Regulatory and Medical Affairs Department headed by Dr. Melodie R. Domurad, PhD," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We are very excited about the initiation of this important study."

Merit Medical is a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy.  It has recently added the BioSphere microsphere products to its line of tumor treatment options.

The phase 3 study is a prospective, randomized, blinded and controlled investigation of HepaSphere/QuadraSphere Microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. Known as the HiQuality Study (HepaSphere/QuadraSphere in Liver Cancer Treatment), the primary endpoint of the clinical trial is survival.  Secondary endpoints include tumor response by mRECIST criteria, safety, resource utilization such as length of hospitalization, and adverse events.  The study will enroll 500 patients and be conducted in approximately 20 clinical sites in the U.S., Europe, and South America.