Is GI Dynamics teasing comeback with offering?

Embattled GI Dynamics has been relatively quiet lately, but the Boston-based company recently revealed its shareholders had approved an offering worth a total of $2 million. The company held a special meeting February 27 to discuss the placement, according to a release. Could the offering help GI Dynamics continue to develop its EndoBarrier device – a technology designed to treat obesity in patients with Type 2 diabetes, that has come under fire in the past? The device works by creating a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are supposed to be similar to gastric bypass surgery, but without the surgical procedure and hospital stay. The idea behind the device is that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. To say GI Dynamics has faced setbacks and hurdles with the EndoBarrier would be an understatement. The most recent roadblock with the device came in November of last year when the company said it had received notification from its notified body SGS United Kingdom, Limited (SGS) that its CE mark was withdrawn. In May of last year,  the company had its CE mark suspended. The company lost European approval because it needed to address nonconfor...
Source: MDDI - Category: Medical Devices Authors: Tags: Medical Device Business Source Type: news

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This study included patients who underwent primary laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG). The primary outcome of interest was incisional SSI occurring within 30  days. Surgeries performed in 2015 were used in a derivation cohort and the predictive tool was validated against the 2016 cohort. A forward selection algorithm was used to build a logistic regression model predicting probability of SSI.ResultsA total of 274,187 patients were included with 71.7% being LSG and 28.3% LRYGB. 0.7% of patients had a SSI in which 71.0% had an incisional SSI, and 29.9% had an organ/spa...
Source: Surgical Endoscopy - Category: Surgery Source Type: research
Objective: We sought to compare the short and long-term outcomes of MBS in adolescents vs. adults who have undergone a Roux-en-Y gastric bypass (RYGB) or Sleeve gastrectomy (SG).Design: Retrospective cohort study.Setting: Single tertiary care academic referral center.Participants: One hundred fifty adolescent (≤ 21-years) and adult (>21-years) subjects with severe obesity between 15 and 70 years of age who underwent RYGB or SG.Outcomes: Metabolic parameters, weight and height measures were obtained pre-and post-surgery (at 3 and 6 months, and then annually for 4 years).Results: Median pre-surgical body mass index (BM...
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
AbstractBackgroundRevisional gastric bypass (R-RYGB) surgery is utilized for the management of inadequate weight loss or weight regain observed after some cases of bariatric surgeries. Data on the mid-term effectiveness of primary gastric bypass (P-RYGB) compared with R-RYGB (e.g., post sleeve gastrectomy/gastric banding) are controversial.MethodsRetrospective chart review of all patients who received P-RYGB and R-RYGB (January 2011 –June 2015) at our center. One hundred twenty patients who underwent P-RYGB and 34 R-RYGB who completed 18 months follow-up were included. We compared the effectiveness of P-RYGB with R-R...
Source: Obesity Surgery - Category: Surgery Source Type: research
In patients with both severe obesity and diabetes, bariatric surgery can often improve diabetes, and in some, gastric bypass is even more effective than sleeve gastrectomy, a study has found.Medscape Medical News
Source: Medscape General Surgery Headlines - Category: Surgery Tags: Diabetes & Endocrinology News Source Type: news
Type 2 diabetes (T2DM) is closely associated with obesity. Given that weight loss is associated with T2DM remission, there has been intense interest in diabetes outcomes following bariatric surgery. The landmark Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial found that bariatric surgery was a more effective diabetes treatment compared with medical management after 5 years of follow-up. While it was not adequately powered to detect differences between Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), other randomized clinical trials have found no differences in diabet...
Source: JAMA Surgery - Category: Sports Medicine Source Type: research
ConclusionsMild-to-moderate PPHG is a frequent complication after bariatric surgery and results in smaller weight loss after 2  years. Age, baseline BMI, and an earlier glucose peak during OGTT predict PPHG after bariatric surgery.
Source: Obesity Surgery - Category: Surgery Source Type: research
CONCLUSION: This study reports similar T2DM resolution rates by both LRYGB and LSG during 1-5 years of follow-up. However, long-term follow-up of 10 years is needed to further substantiate these findings. PMID: 32148383 [PubMed - in process]
Source: World Journal of Gastroenterology : WJG - Category: Gastroenterology Authors: Tags: World J Gastroenterol Source Type: research
Authors: Koch TR, Shope TR Abstract Obesity is a major factor in the worldwide rise in the prevalence of type 2 diabetes mellitus. The obesity "epidemic" will require novel, effective interventions to permit both the prevention and treatment of diabetes caused by obesity. Laparoscopic vertical sleeve gastrectomy is a newer bariatric surgical procedure with a lower risk of complications (compared to Roux-en-Y gastric bypass surgery). Based in part on restriction of daily caloric intake, sleeve gastrectomy has a major role in inducing significant weight loss and weight loss is maintained for at least 10&nbs...
Source: Advances in Experimental Medicine and Biology - Category: Research Tags: Adv Exp Med Biol Source Type: research
Conclusion: Candidates for bariatric/metabolic surgery favored SG followed by AGB, GP, and RYGB, and their choices were compatible with current evidence-based clinical practice. PMID: 32051816 [PubMed]
Source: Annals of Surgical Treatment and Research - Category: Surgery Tags: Ann Surg Treat Res Source Type: research
AbstractIntroductionFactors predicting outcomes after bariatric surgery are yet to be elucidated. We aim to characterize patient-level factors that predict midterm weight loss.MethodsA database of bariatric surgery at a Veterans Affairs (VA) hospital was retrospectively reviewed. Patient characteristics including age, race, sex, median zip code household income, and distance to the VA bariatric center were analyzed for relationships with percent excess body mass index loss (%EBMIL). Univariate and multivariate analyses were conducted to identify factors independently associated with weight loss after accounting for follow-...
Source: Obesity Surgery - Category: Surgery Source Type: research
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