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Long‐term weight loss with a novel minimally‐invasive, restrictive bariatric medical device, the Onciomed Gastric Vest System (47.3)
Author(s) -
Stein Paul,
Nihalani Raj
Publication year - 2014
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.28.1_supplement.47.3
Subject(s) - medicine , curvatures of the stomach , stomach , weight loss , body weight , vest , surgery , gastroenterology , obesity , statistics , mathematics
To demonstrate the applicability of novel implantable medical devices for bariatric use, long‐term large animal studies are necessary. METHODS: Seven female ketamine‐diazepam anesthetized Yorkshire pigs had a three‐port laparoscopic system placed. The greater curvature of the stomach was isolated. A 34‐French Bougie was inserted down the esophagus resting along the lesser curvature. The greater curvature was tucked in along the Bougie and the stomach plicated. An Onciomed Gastric Vest System (GVS) was snugly placed around the stomach and sutured to itself. Three pigs served as controls. At three months, two control and four GVS animals were terminated and a necropsy performed. The remaining were followed for nine months. No post‐surgical complications arose and all animals remained healthy. Animal weights were taken. RESULTS: Different from controls, interest in food was noted to markedly decrease in the GVS animals.GROUP WEIGHT (kg)Day 0 Month 1 Month 2 Month 3 TOTAL WEIGHT GAIN (+) OR LOSS (‐) CONTROL* Mean 36.3 42.3 45.0 49.0 +36% SD 5.5 1.5 2.8 3.6 12 GVS** Mean 37.5 34.7 31.4 29.6 ‐21% SD 2.0 2.0 1.1 0.7 5Trend ANOVA: *P<0.05; **P<0.0001. At nine months, the control animal weighed 59 kg, gaining 97% from 30.0 kg on Day 0, while the three GVS animals weighed 24.7±2.5 kg (P<0.0001), losing 31±10% from 36.2±2.3 kg on Day 0. At necropsy, all animals had normally appearing abdominal organs. The internal surface of the stomachs of all animals also appeared normal. CONCLUSIONS: The Onciomed GVS is highly effective at promoting long‐term weight loss with no apparent adverse effects.