FDA approves Kerecis Omega3 SecureMesh fish-skin surgical mesh

Kerecis said today that it won 510(k) clearance from the FDA for its Kerecis Omega3 SecureMesh regenerative surgical mesh for use in lung, bariatric, gastric, colorectal and other surgeries. The McLean, Va.-based company said the Kerecis Omega3 mesh is made from intact fish skin saturated in naturally occurring Omega3 polyunsaturated fatty acids. Kerecis said the material is designed to regenerate human tissue and “has the potential to accelerate healing.” “With diabetes and obesity so common today, improved surgical technologies are needed to cope with more stress and tissue mass. Our technology can help improve outcomes by reducing the possibility of leakage from surgical wounds. The FDA approval represents an important milestone for us, as we now have two approved products in the world’s largest market for surgical products,” CEO Fertram Sigurjonsson said in prepared remarks. Kerecis said the Omega3 mesh can be used to strengthen staple lines to reduce leakage during laparoscopic operations. The mesh is designed to “recruit the body’s cells from the tissue surrounding the organ cut” and integrate the cells into the fish skin mesh, which will eventually convert into living tissue. The post FDA approves Kerecis Omega3 SecureMesh fish-skin surgical mesh appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Wound Care Kerecis Source Type: news

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Source: Journal of the American College of Surgeons - Category: Surgery Authors: Tags: Bariatric and foregut Source Type: research
Conclusion: Chinese patients undergoing bariatric surgery tend to achieve maximal weight loss and stabilization between 12 and 24 months postoperatively, instead of at>2 years. The finding of the shorter stabilization interval has importance to earlier intervention of weight loss related conditions and women's conception planning.
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
AbstractBackgroundWhile laparoscopic sleeve gastrectomy (LSG) continues to be the most commonly performed bariatric operation, several variables influence surgeons ’ practice patterns and patients’ decision-making in the type of bariatric procedure to perform. The aim of this study was to evaluate patient factors that influence the decision between laparoscopic Roux-en-Y gastric bypass (LRYGB) versus LSG.MethodsThe Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database was queried for patients undergoing LSG and LRYGB between 2015 and 2017. Univariate analysis and multi...
Source: Surgical Endoscopy - Category: Surgery Source Type: research
SummaryBariatric surgery is associated with a high remission rate of type 2 diabetes mellitus. However, it is unclear whether patients showing remission of diabetes actually have normal blood glucose levels throughout the day. We therefore performed continuous glucose monitoring (CGM) in 15 ambulatory patients showing remission of diabetes after laparoscopic sleeve gastrectomy (LSG) without or with duodenojejunal bypass (DJB) at the time of diabetic remission (12.9 ± 1.8 months after bariatric surgery). The definition of remission of diabetes was based on the American Diabetes Association criteria. The mean, ...
Source: Clinical Obesity - Category: Eating Disorders & Weight Management Authors: Tags: Original Research Article Source Type: research
Abstract The alarming rise in obesity and relative lack of pharmacotherapies to treat, what is becoming a global epidemic, has necessitated that an increasing number of bariatric procedures be performed. Several surgical techniques have been developed during the last 50 years and the advent of laparoscopic surgery has increased the safety and efficacy of these procedures. Bariatric surgery is by a substantial margin, the most efficacious means of achieving sustained weight loss maintenance in patients with obesity. Roux-en-Y gastric bypass surgery (RYGB) elicits the most favourable metabolic outcomes with attendan...
Source: Appetite - Category: Nutrition Authors: Tags: Appetite Source Type: research
Authors: Molero J, Olbeyra R, Vidal J, Torres F, Cañizares S, Andreu A, Ibarzabal A, Jiménez A, de Hollanda A, Moizé V, Flores L Abstract Background: Bariatric surgery (BS) in older obese subjects (>60 years of age) has risen in the past decade and will continue to rise in the coming years due to ageing of the population. Aim: To evaluate the short- (12 months) and long-term (60 months) results of laparoscopic sleeve gastroscopy (LSG) in patients older than age 60. Methods: We performed a retrospective review of patients prospectively included in a database from January 2007 to Decem...
Source: Journal of Obesity - Category: Eating Disorders & Weight Management Tags: J Obes Source Type: research
As with most things worth studying, it feels like the more we uncover surrounding the interconnecting mechanisms that lead to the obesity state the more it seems like we have yet to discover. This principle holds true with bariatric surgery as we continue to uncover more and more protective health benefits of contemporary metabolic procedures, like laparoscopic Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG).1,2 Any bariatric surgeon will tell you that many of these patients enjoy profound physiologic improvements in a weight-independent fashion, that is to say that many patients leave hospital already off of d...
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
CONCLUSIONS: LSADI-S is effective in this retrospective review in achieving good initial weight loss and weight maintenance. Although our data show acceptable nutritional complications, questions still remain because of the retrospective nature of the study. PMID: 32843266 [PubMed - as supplied by publisher]
Source: Surgery for Obesity and Related Diseases : official journal of the American Society for Bariatric Surgery - Category: Surgery Authors: Tags: Surg Obes Relat Dis Source Type: research
CONCLUSION: gastric bypass is an effective method for the resolution of comorbidities and reduction of cardiovascular risk, but it is very important to monitor as many patients as possible, and to report on the long-term results, to determine the real effectiveness of these procedures. PMID: 32686438 [PubMed - as supplied by publisher]
Source: Nutricion Hospitalaria - Category: Nutrition Authors: Tags: Nutr Hosp Source Type: research
no LK Abstract Purpose To analyze, in aged obese patients, the weight loss, comorbidity control, and safety postoperative complications of bariatric surgery by Roux-en-Y gastric bypass technique. Methods Twenty-seven patients who underwent laparoscopic weight-reducing gastroplasty with Roux-en-Y gastric bypass to treat obesity were included. All patients were ≥ 60 years old at the time of surgery. The Wilcoxon test was used for statistical analysis, and a p-value ≤0.05it was considered significant. Results Ten (90.9%) patients with dyslipidemia were cured (p
Source: Acta Cirurgica Brasileira - Category: Surgery Authors: Tags: Acta Cir Bras Source Type: research
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