Pluromed wins FDA approval for kidney stone treatment
September 22, 2009 by MassDevice staff
The Woburn, Mass.-based polymer gel developer wins 510(k) approval from the FDA for its Backstop gel plug.
Pluromed Inc. won 510(k) approval from the Food & Drug Administration for its Backstop polymer gel plug.
The Woburn, Mass.-based firm's product is used during lithotripsy kidney stone treatments that use laser or other energy sources to break up the stones. Backstop uses Pluromed's Rapid Transition Polymers, which are liquid at low temperatures but gel at 98.6 degrees Fahrenheit.
During the lithotripsy, the gel forms a plug above the stones, preventing them from moving during the procedure. Once they're broken up, saline is used to dissolve the plug.
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