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| The Enterra system is implanted close to the stomach.--Courtesy of Medtronuc |
The FDA has approved a second-generation Medtronic ($MDT) device to treat gastroparesis patients who are not able to control nausea and vomiting using drugs. The Enterra II System has been approved under a humanitarian device exemption (HDE), which is used by the agency to approve devices intended for a population of fewer than 4,000 people in the U.S.
An HDE allows companies to simply demonstrate safety and probable benefit. The first version of the device was approved via the HDE pathway in 2000 to treat gastroparesis. The Enterra II System offers improvements to the programming software, the battery life indicator and the customized tool used by physicians to implant the device, according to Medtronic.
Gastroparesis involves malfunctioning stomach muscles that cause nausea and vomiting. It has a number of potential causes, but is particularly associated with diabetes. The condition occurs in about 5% of the diabetic population, the company said.
The Enterra system is implanted under the skin, typically in the lower abdomen. Two lead wires are implanted in the stomach wall and connect to the neuostimulator. These deliver mild electrical pulses to the smooth muscles of the lower stomach. After implantation, a physician uses a hand-held, external programmer to noninvasively adjust the neurostimulation.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting," Dr. Henry Parkman, a professor of Medicine at Temple University School of Medicine and Director of the GI Motility Laboratory at Temple University Hospital, said in a statement. He is one of the first physicians to implant the Enterra II System. "The new advanced system simplifies the implantation process and is easy to program."
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