U.S. Experience with Technomed International Sonolith 3000: Gallstone Lithotripsy and Ursodeoxycholic Acid

Abstract

Technomed’s Sonolith 3000 dual-purpose, electrohydraulic, transportable and fixed site biliary lithotripter is currently undergoing gallstone lithotripsy (GSL) trials at six United States institutions: Thomas Jefferson Hospital, Philadelphia; Alton Ochsner Clinic, New Orleans; Methodist Hospital, Houston; Methodist Hospital, Omaha; Sentara Norfolk General Hospital, Norfolk, and Therapeutic Technologies, Seattle.

GSL is accomplished utilizing ultrasound localization with the Sonolith’s multi-articulated arm. The arm’s six degrees of movement allow the identification of the spatial coordinates of the stone, permitting the computer to correctly position the diatron self-adjusting, spark gap generator. Real-time ultrasound imaging is used to study the progress of stone fragmentation.

The current U.S. trial began in the summer of 1988. The protocol employs lithotripsy and adjuvant ursodeoxycholic (UDC) acid to examine the effectiveness of treating up to three gallstones with a total stone burden not exceeding 46 mm. Only one retreatment is allowed, and all patients are being followed for at least six months post-GSL. This paper presents the collective preliminary data from these six American Technomed biliary IDE sites.