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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ConclusionThis study suggests that bariatric surgery is only a prerequisite for weight loss, and the long-term dietary control and exercise can help patients achieve optimal weight loss.
Source: Diabetes Therapy - Category: Endocrinology Source Type: research
ConclusionOAGB provided very good weight loss, comorbidity improvement, and quality of life at follow-up of ≥ 5 years.
Source: Obesity Surgery - Category: Surgery Source Type: research
ConclusionThe results demonstrated a positive relationship between post-LSG serum zinc levels and preservation of renal function among patients with obesity in a surgical setting. Large-scale studies are warranted to support the findings.
Source: Obesity Surgery - Category: Surgery Source Type: research
ConclusionWLG group did not have decreased perioperative morbidity, nor improved weight loss and comorbidity resolution 4 years after surgery. While these findings should also be confirmed by multicenter trials, they question the value of mandated WLG prior to bariatric surgery as they seem ineffective and may limit patient access to surgery.
Source: Obesity Surgery - Category: Surgery Source Type: research
AbstractBackgroundThe safety and efficacy of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) to treat obesity and associated comorbidities, including diabetes mellitus, is well established. As diabetes may add risk to the perioperative period, we sought to characterize perioperative outcomes of these surgical procedures in diabetic patients.MethodsUsing the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database, we identified patients who underwent LSG and LRYGB between 2015 and 2017, grouping by non-diabetics (NDM), non-insulin-dependent dia...
Source: Obesity Surgery - Category: Surgery Source Type: research
We examined the correlation between preoperative glycemic control and postoperative complications in patients undergoing bariatric surgery.
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
We report the case of a 26-year-old man with PWS and morbid obesity (BMI 65kg/m2) since childhood. He also suffered from uncontrolled diabetes mellitus type 2, hypertension, and obstructive sleep apnea. After an unsuccessful diet and exercise program, he opted for bariatric surgery in which laparoscopic sleeve gastrectomy was performed.
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
While there exists robust data to suggest that laparoscopic sleeve gastrectomy (LSG) is successful in the treatment of type II diabetes mellitus, there remains a paucity of evidence on the use of this surgery in patients with type I diabetes mellitus (T1DM). Previous literature looking into bariatric surgery for patients with T1DM has primarily focused on Roux-en-Y gastric bypass, which is now less commonly performed than LSG in the United States.
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
Recent guidelines on diabetes treatment provide that weight loss should be the most logical and cost-effective means of controlling T2D. Bariatric surgery is now considered the most effective and durable weight loss intervention. Objectives: To compare laparoscopic one anastomosis gastric bypass (OAGB) and laparoscopic sleeve gastrectomy (SG) regarding the efficacy of control of T2D in obese patients.
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
Stapling of a bougie, temperature probe, or a nasogastric tube is a rare and poorly reported complication of bariatric surgery that can lead to significant morbidity in patients. The best management of such a complication is unclear. Patient is a 55-year-old gentleman with a BMI 35 kg/m2, hypertension, type 2 diabetes mellitus and obstructive sleep apnea. Patient underwent a laparoscopic sleeve gastrectomy using a 34Fr Bougie. At the end of the case, attention was brought to the fact that the tip of the oral temperature probe was missing.
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
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