Medtronic (NYSE:MDT) today said it won a humanitarian device exemption for its Enterra II device, a neurostimulation implant designed to treat the stomach disorder gastroparesis.
The stomach muscles of patients with gastroparesis function poorly or not at all, preventing it from emptying and interfering with digestion. The Enterra II device is designed to treat the nausea and vomiting that often accompanies gastroparesis in patients who can’t take drugs to treat the condition, Medtronic said, noting that about 5% of diabetics are estimated to suffer from gastroparesis.
The Enterra device is implanted under the skin of the abdomen and connected via leads to the stomach wall muscle. It’s designed to deliver mild electrical impulses to the smooth muscles of the lower stomach to induce motility, according to a press release. The latest iteration of the device features improved programming software, a better battery life indicator and a simpler implantation procedure, Medtronic said.
"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," gastro/urology therapies general manager Linnea Burman said in prepared remarks. "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."
Medtronic said Dr. Henry Parkman of Philadelphia’s Temple University Hospital was among the 1st to implant the Enterra II device (Medtronic said that neither Dr. Parkman or his immediate family has a financial interest in the company).
"Enterra therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting," Parkman said in a statement. "The new advanced system simplifies the implantation process and is easy to program."