Medtronic, Inc. has announced it has received United States Food and Drug Administration (FDA) approval, under a humanitarian device exemption (HDE), for the Medtronic Enterra II System. The system is used to treat chronic, intractable (drug-refractory) nausea and vomiting associated with gastroparesis of diabetic or unknown origin when more conservative treatments fail or cannot be tolerated. Gastroparesis is a serious and debilitating condition with no known cure in which the stomach muscles work poorly or not at all. It has many possible causes and is of particular concern to the increasing U.S. diabetes population, as it is estimated to affect about fivepercent of people with diabetes. Medtronic Enterra Therapy consists of a small medical device called a neurostimulator, which is implanted under the skin, usually in the lower abdominal region. Two insulated wires, called leads, are implanted in the stomach wall muscle and then connected to the neurostimulator, which delivers mild electrical pulses through the leads to stimulate the smooth muscles of the lower stomach. After the device is implanted, the doctor uses a handheld, external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient’s needs.
Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer. While Medtronic Enterra Therapy has been available to patients since 2000, the new Enterra II System improves the therapy by providing physicians with greater system flexibility and ease of use. The Enterra II System features improved programming software, improvements to the system’s battery-life indicator, and a customized tool that simplifies implantation of the device for physicians. Henry P. Parkman, M.D., Professor of Medicine at Temple University School of Medicine, and Director of the GI Motility Laboratory at Temple University Hospital, is one of the first to use the Enterra II System. Neither Dr. Parkman nor any member of his immediate family has any financial interest in Medtronic. “Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting,” said Dr. Parkman. “The new advanced system simplifies the implantation process and is easy to program.” “Medtronic Enterra Therapy is a well-established treatment option, and we are pleased to make the new Enterra II System available to physicians and patients,” said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic.