Holmium Lasers Cleared for Use in Gastrointestinal Surgery

FDA has granted clearance to Trimedyne Inc. (Irvine, CA) to market its Holmium lasers and associated disposable devices for a variety of uses (incision, resection, ablation, vaporization and coagulation) in gastroenterological and gastrointestinal (GI) surgery.

Among the cleared GI surgery uses are excision and coagulation of colorectal cancer and other tumors, coagulation of ulcers, removal of hemorrhoids, fragmentation of gall bladder and bile duct stones, appendectomy and lysis (separation) of adhesions.

Trimedyne's Holmium "cold" lasers deliver very high energy pulses (peak power 10,000 W) in an extremely short period of time (350 microseconds). Tissue exposed to these high energy pulses is instantly vaporized, with minimal thermal damage to adjoining tissues.

Because Holmium laser energy penetrates tissue to a depth of only 400 µm (1/64 in.), its action is much more precise than Argon, Diode, KTP or Nd:YAG lasers, whose energy penetrates tissue five to 10 times further to a depth of two to four mm (1/12 to 1/6 in.). At low energy, Trimedyne's Holmium lasers coagulate blood vessels, stopping bleeding.

Edited by Ursula Jones