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Back To Vidyya FDA Approves Incision-Free Lithotripsy Method For Gallstone Removal

Therapy Combines Oral Medication And Lithotripsy To Move Calculi From Gallbladder

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. Developed by Medstone International, the combination therapy uses shockwave lithotripsy and a drug to breakdown the gallstones so that the body may expel them. The new procedure will soon be available at medical centers where Medstone lithotripters are in use for the treatment of kidney stones. A patient information and referral network, called GAIN for the Gallstone Awareness & Information Network, helps direct patients seeking early diagnoses and treatment to medical centers in their area offering the new procedure.

"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 $5 billion per year.

Gallstones are formed when the gallbladder is unable to maintain the acidic environment that prevents calcium and other substances from forming solid particles. The gallbladder is part of the human body's own "ecological" system that depends on a number of functions to work properly in order to maintain a consistent flow of bile through the body's digestive system. When one part of this system isn't working, the sludge-like contents of the gallbladder crystallize and form "stones". These stones cause pain when one is small enough to move through ducts leading from the gallbladder or to other ducts in the digestive system.

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 (NYSE: NVS). 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% 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."

Consumer Information Available

A free informational brochure and referral hotline are now available to consumers calling (800) 600-7111 x 260 or writing The brochure lists the medical centers offering the procedure.

Medstone says the opportunity to treat a large number of gallstone sufferers is promising.

"It is estimated that seven to eight million Americans with gallstones may match the criteria to be treated by a combination of lithotripsy and drug therapy," stated Eva Novotny, executive vice president of sales and marketing. "For the average person with gallstones, it is a compelling option to have the possibility of being cured of the disease and still retain a functioning and intact gallbladder for another 30 years of life."

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Editor: Susan K. Boyer, RN
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