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[IP] New Device gastroparesis

     I saw this in my health news on the web. Just wanted to share
     FDA Approves Stomach 'Pacemaker' 
     Updated 3:26 AM ET April 7, 2000 
     Current quotes (delayed 20 mins.) MDT  56 1/16  1/8  (0.22%)  
      By LAURAN NEERGAARD, AP Medical Writer 
     WASHINGTON (AP) - Jennifer Sivils was a healthy mother of three when 
     suddenly she got a mysterious stomach disorder that literally was 
     starving her to death. She simply could not hold down any food and her 
     weight dropped from 157 pounds to 98. 
     Severe gastroparesis left her stomach unable to churn properly to move 
     food down the digestive tract. Intravenous nutrition kept her alive. 
     But then she got an experimental pacemaker-like device that zapped her 
     stomach with little electric shocks. She since has regained 22 pounds 
     and can eat certain foods again. 
     Swayed by cases like Sivils', the Food and Drug Administration has 
     approved the sale of Medtronic Corp.'s Enterra implant for up to 4,000 
     Americans a year who suffer severe cases of this baffling stomach 
     Enterra is not a cure. But in a small study many implant recipients 
     dramatically improved, said Dan Schultz, FDA's director of abdominal 
     Some 100,000 people may suffer some degree of gastroparesis. Diabetes 
     causes many cases, but about a third have no known cause. 
     In mild cases, the stomach just takes longer to digest food. Eating 
     smaller portions of easy-to-digest food and certain stomach 
     medications helps many patients. But people with severe cases cannot 
     eat, sometimes even drink, because of continual nausea, vomiting and 
     pain. The sickest survive with feeding tubes inserted into the 
     intestine or total intravenous nutrition. 
     The theory behind Enterra: The shocks stimulate nerves lining the 
     stomach that control how it digests food, said University of Kansas 
     gastroenterology chief Dr. Richard McCallum, who helped test the 
     It is the same rationale behind other neurostimulators that ease 
     tremors by zapping a brain nerve, and ease incontinence by zapping a 
     nerve that controls the bladder. 
     The Enterra theory is not proved, Schultz said. Enterra has been 
     studied on so few people - 33 - that the FDA wonders if a placebo 
     effect from simply having surgery could explain some of the benefit. 
     The 33 patients, who all failed gastroparesis medications, on average 
     vomited 48 times a week before the implant. After surgery, vomiting 
     episodes averaged 23 times a week when Enterra was turned on and 29 
     times a week when it was turned off. While patients felt better 
     regardless, those similar numbers puzzled scientists. 
     Then the stimulator was turned on again for good, and some patients 
     steadily improved. A year later, vomiting averaged 10 times a week. 
     Some patients can eat fairly normally with little nausea while others 
     had less benefit - "a tremendous amount of variability," Schultz 
     Still, the effect seemed important enough that FDA approved Enterra on 
     March 31 under a special rule allowing "humanitarian" treatments for 
     rare, lifethreatening disorders to sell without extensive clinical 
     trials. Medtronic disclosed the approval Thursday, saying the device 
     is immediately available. 
     Enterra is a battery-powered generator implanted in the abdomen with 
     an electrode snaked up to the stomach muscle. It emits low-voltage 
     shocks about once every six seconds. It is a $26,000 operation. 
     Getting Enterra to market was a battle - an initial study was not 
     promising and a skeptical Medtronic wanted to pull the plug, McCallum 
     But desperate patients begged to try Enterra. The FDA offered the 
     special "humanitarian" review, and McCallum said Medtronic allowed him 
     and University of Tennessee gastroenterologist Dr. Thomas Abell to 
     complete the study. 
     Abell implanted Sivils' device last August. About a month later, she 
     started noticing gradual improvement. 
     She is not cured - she still gets IV nutrition three days a week. But 
     she eats vegetables and soups without vomiting for the first time in 
     two years and can play with her children again. 
     "It's sad to think you could starve to death here in the United States 
     because of a disease," said Sivils, 35, of Arkadelphia, Ark. "I'm so 
     grateful" for the device. 
     On the Net: http://www.medtronic.com/neuro/enterra 
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