DevicePMAs@therightstef:P970042_S000 JSONTXT 13 Projects

Approval for the medstone sts(tm) lithotripter in conjunction with actgall(r). When used with the drug, this device is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adult patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery. Combination therapy consists of 1) administration of actigall(r) (8-10 mg/kg/day) for at least two weeks pre-lithotripsy, 2) lithotripsy treatments of up to 2000 24 kv shocks, and 3) continued administration of actigall(r) until a stone-free state is achieved.