To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Combination Lithotripsy/Actigall (Ursodio) Therapy Approved In US For Gallstones URL: http://www.pslgroup.com/dg/1E0EE6.htm Doctor's Guide September 13, 2000
WASHINGTON, DC -- September 13, 2000 -- A new treatment for gallstone disease without an incision has received Food and Drug Administration (FDA) approval, and promises to be an attractive, less expensive option for the 25 million Americans who suffer from the disease, who refuse surgery or who are not good candidates for surgery, especially in its early stages. "We are very pleased to receive this clearance to market our Medstone lithotripsy therapy system to treat gallstone disease -- this system has been used to treat kidney stones for over 10 years. We will conduct ongoing studies to further demonstrate the effectiveness of this option for gallstone disease," said David Radlinski, chairman and CEO of Medstone International, Inc. "Surgery will still be needed for patients with advanced disease, but patients who have a single small stone causing symptoms with an otherwise healthy gallbladder who refuse surgery or who are not good candidates for surgery, could benefit from lithotripsy therapy in combination with medication. This new therapy would allow those patients to keep an otherwise healthy gall bladder. Patients with symptoms are encouraged to visit their doctors early to see if this option is right for them." According to the National Institutes of Health, gallstone disease causes 500,000 Americans, two-thirds of them women, to lose their gall bladders each year, and the cost for operations and hospitalization exceeds US$5 billion per year. This new gallstone treatment therapy combines Medstone's lithotripsy technology with short-term use of Actigall, a gallstone dissolving drug manufactured by Novartis Pharma AG. Clinical studies have indicated that the combination therapy can speed up clearance of gallstones and result in higher success rates compared to drug therapy alone in carefully selected patients. Until now, people who suffered from gallstones had few options other than long-term use of expensive medications that dissolve the stones or surgery to remove the entire gallbladder. Physicians involved in the clinical studies of Medstone's Lithotripsy Therapy System believe this new treatment will provide patients who have a solitary stone causing symptoms who otherwise have a healthy and functioning gallbladder a new alternative to treat their disease yet keep their gallbladder. "This new treatment option gives us the chance to treat patients suffering from gallstones during the early stages of gallbladder disease and prevent the need to remove the gall bladder," said Michael Albert, MD, a gastroenterologist at George Washington University Medical Center in Washington, DC and principal investigator for Medstone's post-approval clinical studies. In a clinical article from Seminars in Liver Disease entitled "Extracorporeal Shock-wave Lithotripsy of Gallstones with the Adjuvant Use of Cholelitholytic Bile Acids" Dr. Albert writes, "Although only 15 to 20 percent of these patients will go on to develop biliary symptoms or complications, early treatment of stones while they are small, few in number, and not causing problems might be cost-effective, particularly if the treatments can be shown to be safe, effective, and able to be performed on an outpatient basis." --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.