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,i as it is estimated to affect about five percent of people with diabetes.ii
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. “These therapy enhancements are the latest examples of our ongoing commitment to provide physicians with a therapy that eases life-altering gastroparesis symptoms and enables patients to more comfortably participate in the things they enjoy.”
Enterra Therapy has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Complications related to the device also can occur and may require additional surgery. Additional information on Medtronic Enterra Therapy is available at www.enterratherapy.com.
* Humanitarian Device: Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70. The effectiveness of this device for this use has not been demonstrated.
i. Camilleri M, Bharucha A, Farrugia G. Epidemiology, Mechanisms and Management of Diabetic Gastroparesis. Clin Gastroenterol Hepatol. January 2011 ; 9(1): 5-e7.
ii. Jung H-K, Choung RS, Locke GR, 3rd, et al. The Incidence, Prevalence, and Outcomes of Patients With Gastroparesis in Olmsted County, Minnesota, From 1996 to 2006. Gastroenterology. Apr 2009; 136 (4): 1225-1233.
Source: Medtronic, Inc.