SAFETY and PROBABLE BENEFIT GASTRIC ELECTRICAL STIMULATION

Worldwide Anti-Vomiting Electrical Stimulation Study

In a multicenter clinical study¹ (WAVESS – Worldwide Anti-Vomiting Electrical Stimulation Study), a majority of patients experienced improvements in weekly vomiting episodes after receiving an Enterra^TM implant compared to the number of vomiting episodes before GES. The Enterra Therapy Clinical Summary contains details of the study.

Thirty-three (33) patients with chronic gastroparesis* were enrolled in WAVESS (17 of diabetic origin and 16 of idiopathic origin). Symptoms were compared between baseline and 6 and 12 months. 

At both follow-ups and for both patient groups, the median weekly vomiting episodes were significantly reduced:

• At 6 months after implant, the median vomiting frequency declined 80% for the diabetic group and 88% for the idiopathic group (n = 27)
• At 12 months after implant, the median vomiting frequency declined 63% for the diabetic group and 83% for the idiopathic group (n = 24)

Evaluation of secondary endpoints showed many patients experienced improvement in²:

• Quality of life (73%)
• Ability to tolerate solid meals (73%)

Also, there was a trend in improvement for gastric retention, subjective symptoms, and hypoglycemic attacks.²

Common Adverse Events

Common system-related adverse events during the WAVESS study included device infections, lead penetration, irritation/inflammation over the neurostimulator site, pain at neurostimulator site, and mechanical or electrical problems with device.