Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approval of Intragastric Balloon System

Device assists adults with weight management

Publish date:: August 18, 2015

Indications: The ORBERA Intragastric Balloon System is indicated for adult obese patients who have a body mass index (BMI) of 30 to 40 kg/m² who have been unable to lose weight through diet and exercise.

Mechanism of action: The temporary system is placed into the stomach through the mouth, helps patients lose weight and should be removed after 6 months.

Efficacy and safety: In a clinical trial, 255 patients who used the system lost an average of 22 pounds. The device should not be used in patients who already have an intragastric balloon, have had prior gastrointestinal or bariatric surgery, or have any inflammatory disease of the GI tract.

Citation: FDA website. ORBERA intragastric balloon system. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapp.... Updated August 6, 2015. Accessed August 11, 2015.

This Week's Must Reads

HIV, Cancer Treatment, and Prostate Cancer Outcomes Among Elderly Adults,

Low Natural Killer Cell Activity Increases PCa Risk in Veteran Men Undergoing Biopsy,

Prostate CE-TRUS Evaluation with Whole Mount Prostatectomy Correlation,

Testosterone Accumulation in PCa Cells Enhanced by Facilitated Diffusion,

Characterization of GLYATL1 in Prostate Cancer,

Must Reads in Obesity

Physical Activity & Incidence of CHD & CVD in Women, JAMA Netw Open; ePub 2019 Mar 15; LaCroix, et al

Coffee Consumption & Plasma Biomarkers, Am J Clin Nutr; ePub 2019 Mar 5; Hang, et al

Fitness & BMI in Adolescence Tied to Adult Disability, Ann Intern Med; ePub 2019 Feb 12; Henriksson, et al

BMI Measurements and Intensive BP Management , Am J Med; ePub 2019 Feb 2; Oxlund, et al

Adiposity and Risk of Decline in GFR, BMJ; ePub 2019 Jan 10; Chang, Grams, et al