Pluromed Inc won 510(k) approval from the FDA for its Backstop polymer gel plug. The plug 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 the stones are broken, saline is used to dissolve the plug.

The FDA has granted 510(k) marketing clearance to EDAP for its newly designed, high-end Sonolith I-Sys robotized device. Sonolith I-Sys has been developed to provide a highly effective product configuration to address what is one of the largest lithotripsy markets in the world. The integrated lithotripter utilizes EDAP’s unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined x-ray or ultrasound systems.

The NGage Nitinol Stone Extractor, manufactured by Cook Medical, represents an entirely new category in the evolution of stone extraction. Utilizing the revolutionary nitinol technology, NGage allows physicians to easily engage, release and extract stones even in the most difficult anatomy while providing improved irrigation, visibility and enhanced efficiency. In recent clinical evaluations, the breakthrough NGage proved more effective than standard devices in grasping and holding fragments in the kidney and urinary tract. Its retention strength was also demonstrated to be 1.5 times stronger than traditional graspers.