FDA Approves Trimedyne's Holmium Lasersfor Gastrointestinal Surgery

IRVINE, Calif., Nov. 5 -- Trimedyne Inc. said that the US Food and Drug Administration has cleared the way for the company to market its holmium lasers and associated disposable devices for a variety of uses in gastroenterological and gastrointestinal (GI) surgery. The approved uses in GI surgery include the excision and coagulation of colorectal cancer and other tumors; fragmentation of gall bladder and bile duct stones; removal of hemorrhoids; coagulation of ulcers; appendectomy; and lysis, or separation, of adhesions. The company noted that these conditions affect hundreds of thousands of individuals each year in the US.
In commenting on the FDA action, Marvin P. Loeb, Trimedyne's chairman, noted, This FDA clearance will enable us to expand the market for our Holmium lasers from the urology, orthopedic, ENT and gynecology fields into the gastro market, where multiple uses for our lasers and disposables are possible. Also, the ability of our Holmium laser to be used in a variety of departments of a hospital makes its purchase more economically feasible.