Merit Medical received FDA 510(k) clearance for its EmboCube embolization gelatin.
EmboCube is used in the embolization of hypervascular tumors. It features uniformly cut cubes of gelatin foam that have been designed to address preparation concerns and inconsistent particle sizes that come with traditional gelatin foam sheets as an embolic. Embocube gets preloaded into a Medallion syringe to deliver the gelatin smoothly and with minimal to no resistance.
Physicians have to manually prepare gelatin foam before use when using traditional gelatin foam sheets as an embolic agent.
“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,” said Fred Lampropoulos, chairman and CEO of Merit Medical, in a press release. “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 comes in 2.5mm and 5.0mm sizes. The 2.5mm EmboCube is compatible with the company’s EmboCath Plus and Merit Maestro microcatheters with a 0.024 in. or larger inner diameter. The 5.0mm EmboCube can be delivered through catheters with a 0.040 in. or larger inner diameter.