Cindy
“This device has changed my world. I feel like I have a life again.”
Mary
“I have my life back…even more so than I could have ever imagined”
Shannon
“Keep going and keep fighting…don’t give up.”
Judith
“I’m able to do what I love to do. Life is good.”
James
“I feel like I have everything going for me”
MKT-D-0006, Rev L
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
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 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?