EmboCube embolization gelatin granted FDA approval for embolization of hypervascular tumours

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embolization
EmboCube (Merit Medical)

EmboCube Embolization Gelatin (Merit Medical) has been granted 510(k) approval for use in embolization of hypervascular tumours.

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, a press release states. EmboCube is preloaded in a Medallion syringe for smooth delivery with minimal to no resistance.

Using traditional gelatin foam sheets as an embolic agent requires the physician to manually prepare the gelatin foam before use, which can be messy and time consuming, and can result in inconsistently sized particles that may clog the delivery catheter or lead to nontargeted embolization.

“I have witnessed many times physicians preparing gelatin foam for endovascular use. They often use a scalpel to cut the gelatin foam, which can be dangerous, and no matter how carefully cut, the particle sizes are inconsistent,” says Fred Lampropoulos, chairman and CEO of Merit Medical. “We designed EmboCube to make the process of using a gelatin embolic faster, easier and more efficient so the physician can focus on the patient.”

EmboCube Embolization Gelatin is available in two sizes: 2.5mm and 5mm. The 2.5mm EmboCube is compatible with the EmboCath Plus and Merit Maestro microcatheters with a 0.024” (0.62 mm) or larger inner diameter. The 5mm EmboCube can be delivered through catheters with a 0.040” (1.02mm) or larger inner diameter. EmboCube is intended for use with an EmboCube Delivery Kit (Merit Medical) that includes two injection syringes (one mL and three mL) and a three-way stopcock for added convenience.

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