Medstone Receives Recommendation For Approval From FDA Panel For Treatment of Gallstones.ALISO VIEJO, Calif.--(BW HealthWire)--May 1, 1998--Medstone International Inc. (Nasdaq: MEDS meds A popular term for physician-prescribed medications ) has been notified that the FDA's Gastroenterology and Urology Device Advisory Panel has recommended conditional approval of Medstone's submission to treat gallstones Gallstones Definition A gallstone is a solid crystal deposit that forms in the gallbladder, which is a pear-shaped organ that stores bile salts until they are needed to help digest fatty foods. using the company's lithotripter lithotripter /litho·trip·ter/ (lith´o-trip?ter) an instrument for crushing calculi in lithotripsy. lith·o·trip·ter n. , in combination with Actigall, a drug used to dissolve gallstones. The condition to approval is that Medstone performs a post-approval study. "The recommendation for approval is another step along the approval trail. This step was taken after many years of hard work by a group of talented people. We believe this combined therapy will be a valuable tool for the physicians in treating certain patients with gallstones," said David V. Radlinski, chairman and chief executive officer. Medstone, as the only vertically integrated extracorporeal shockwave therapy Extracorporeal Shock Wave Therapy or ESWT is a method of treatment of kidney stones (Extracorporeal Shockwave Lithotripsy), shoulder tendinitis, and other conditions by application of high-intensity ultrasonic acoustic radiation. ("ESWT ESWT Extracorporeal shock wave lithotripsy, see there ") company, is focused on providing cost effective lithotripsy for treatment of various diseases. CONTACT: Medstone International Inc. David V. Radlinski, 714/448-7700, Ext. 235 |
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