The FDA approved a surgical gel designed to temporarily stop blood flow during procedures.
The water-soluble, low-viscosity gel designed by Woburn, Mass.-based Pluromed forms a plug at body temperature to temporarily stent blood vessels without damaging them.
"LeGoo is an innovative device that offers surgeons an additional aid during vascular surgery," Christy Foreman, of the FDA’s Center for Devices and Radiological Health, said in prepared remarks. "The gel’s unique properties may facilitate surgeries that entail the joining or grafting of blood vessels."
After procedures, the gel dissolves on its own within 15 minutes, according to the FDA. If surgeons need the gel to dissolve sooner they can apply cold packs or cold saline to the vessel.
Pluromed’s Backstop gel plug, for use during lithotripsy kidney stone treatments, landed 510(k) approval in 2009.
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