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.
Pluromed won a $500,000 accelerator loan in April from the Mass. Life Sciences Center.
The FDA nod is Pluromed’s first, but the Backstop product is already approved in Europe and Canada, according to a company press release.
Pluromed is also developing an injectable plug for cardio-thoracic surgery, the LeGoo Internal Vessel Occluder, which is approved in Europe.