Merit Medical Receives FDA Clearance for EmboCube Embolization Gelatin
November 29, 2018—Merit Medical Systems, Inc. announced that it has received FDA 510(k) clearance for EmboCube embolization gelatin. EmboCube is indicated for use in embolization of hypervascular tumors.
According to the company, the uniformly cut cubes of gelatin foam have been specifically designed to address preparation concerns and inconsistent particle sizes associated with using traditional gelatin foam sheets as an embolic. EmboCube is preloaded in Merit Medical's Medallion syringe for smooth delivery with minimal to no resistance.
EmboCube embolization gelatin is available in two sizes, 2.5 and 5.0 mm. The 2.5-mm EmboCube is compatible with the company's EmboCath Plus and Merit Maestro microcatheters with a 0.024-inch (0.62-mm) or larger inner diameter. The 5.0-mm EmboCube can be delivered through catheters with a 0.04-inch (1.02-mm) or larger inner diameter. EmboCube is intended for use with Merit Medical's EmboCube delivery kit that includes two injection syringes (1 and 3 mL) and a three-way stopcock for added convenience, stated the company.