The labeling updates improve patient safety by providing further definition and guidance on the appropriate use of the ORBERA® Intragastric Balloon System and patient selection.
2/19/19: ESG is an endoscopic minimally invasive weight loss procedure based on full-thickness endoscopic suturing using Apollo’s OverStitch™ device. In the ESG procedure, a series of sutures are placed through the gastric wall reducing the stomach volume by 80% creating a restrictive endoscopic sleeve. The result allows a patient to consume less food and remain satiated longer.
Apollo Endosurgery Announces Presentation of Intragastric Balloon Comparison Study at Digestive Disease Week® 2018 titled: “Fluid-Filled Intragastric Balloons are Superior to Gas-Filled Balloon”
6/4/18: “Gastric emptying is the key to how ORBERA helps patients lose weight. When a patient has an ORBERA balloon in their stomach it acts like a valve that slowly allows food they eat to pass through their stomach. Without a balloon a normal meal will typically pass through a patients stomach in 20-30 minutes. Now with an ORBERA balloon in their stomach, we have data that a large portion of that meal would still be in their stomach 2 hours after eating. This delayed emptying helps patients feel full, helps them learn proper portion control and most importantly helps them lose a clinically significant amount of weight,” said Dr. Christopher Gostout, MD, Chief Medical Officer at Apollo.
5/14/18: The study will involve four National Health System Hospitals, led by Professor José Luis Calleja, MD from Hospital Universitario Puerta de Hierro Majadahonda - Universidad Autónoma de Madrid, as Principal Investigator.
The FDA has approved the termination of the LAP-BAND® Lower Body Mass Index (BMI) Post-approval study (“LBMI Study”) announced today by Apollo Endosurgery, Inc. In 2011, the U.S. FDA granted approval for an expanded indication for the LAP-BAND...
Apollo Endosurgery Announces Presentation of the Brazilian Intragastric Balloon Consensus Statement at ObesityWeek
According to the company, this presentation reported the results of a consensus meeting held in Sao Paulo, Brazil in June 2016 of 39 endoscopists with up to 17 years of experience providing intragastric balloon therapy to patients.
Apollo Endosurgery Announces CE Mark Approval for the ORBERA365™ Managed Weight Loss System, Expanding the Indwell Period from 6 Months to 12 Months with the Gastric Balloon Category Leader
Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced CE (Conformité Européene) Mark approval for the ORBERA365 Managed Weight Loss System. The ORBERA365 Managed Weight Loss System...
Apollo Endosurgery, Inc. (NASDAQ: APEN), a medical technology company primarily focused on the design, development and commercialization of innovative medical devices that can be used for the treatment of obesity, today announced the pricing of an underwritten...
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