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Apollo Endosurgery

Apollo gains FDA approval for Polypropylene Suture-Anchor Assembly

Apollo Endosurgery has received 510(k) clearance from the FDA for its Polypropylene Suture-Anchor Assembly for use specifically with the OverStitch Endoscopic Suturing Systems. This proprietary suture-anchor implant is used as part of Apollo’s OverStitch and OverStitch Sx Endoscopic Suturing Systems to pass and anchor suture in the gastrointestinal tract.  The comapny is currently distributing a suture anchor that is manufactured by a third party according to Apollo design specifications.

Apollo Endosurgery sells Lap-Band system to ReShape Lifesciences

Apollo Endosurgery has announced the sale of its surgical product line, which consists of the Lap-Band adjustable gastric banding system and other accessories used in laparoscopic bariatric surgery, to ReShape Lifesciences. The definitive transaction agreements were signed and closed on 17 December 2018. This transaction will allow Apollo to focus all its efforts on growing the clinical adoption of its Endo-bariatric product offerings, which consists of its OverStitch Endoscopic Suturing Systems and the Orbera Intragastric Balloon technologies.

Orbera study and European Endoscopic Suturing Registry

Apollo Endosurgery has completed enrolment in the Orbera Post Approval Study evaluating the Orbera intragastric balloon. This is a multi-centre, open-label, prospective study of the safety and efficacy of the Orberasystem within the US. The study was a requirement of the US FDA’s approval of Orberain August of 2015.

WET: EndoBarrier vs Orbera Intragastric Balloon

Researchers from Germany have established the Weight-loss Endoscopy Trial that will compare weight loss following an endoscopically implanted duodenal-jejunal bypass liner (DJBL, EndoBarrier system GI Dynamics), the Orbera Intragastric Balloon (IB, Apollo Endosurgery) and a sham procedure. According to the WET investigators from the University of Leipzig, Leipzig, the Bogenhausen Clinic, Munich, the University of Freiburg, Freiburg and the University of Hamburg-Eppendorf, Hamburg, Germany, this will be the first randomised comparison between these devices.

Apollo initiates Spanish Endoscopic Sleeve Gastroplasty NASH study

Apollo Endosurgery has enrolled first patient in a multi-centre, randomised, controlled, double-blind study of the efficacy and safety of Endoscopic Sleeve Gastroplasty (ESG) using Apollo’s OverStitch Endoscopic Suturing System, in patients with non-alcoholic steatohepatitis (NASH). The study is funded by a Beca FIS Grant awarded to the Foundation of the Hospital Universitario Puerta de Hierro Majadahonda by the Ministry of Health of the Spanish Government.

Apollo establishes European endoscopic suturing registry

Apollo Endosurgery has announced the establishment of a multi-centre, longitudinal, data repository for Endoscopic Sleeve Gastroplasty (ESG) and gastrojejunal anastomotic outlet revision procedures. These endoscopic, trans-oral procedures allow physicians to place sutures in the upper gastrointestinal tract using a flexible endoscope to reduce stomach volume or revise previous bariatric surgery for patients. The prospective registry will collect outcomes related to the safety and effectiveness of procedures performed with Apollo’s OverStitch Endoscopic Suturing System.

Apollo’s Orbera365 approved in the Kingdom of Saudi Arabia

Apollo Endosurgery has announced that the Saudi Food and Drug Authority (SFDA) has approved the Orbera365 Managed Weight Loss System and has issued a Medical Device Marketing Authorization (MDMA) for the product. This MDMA allows Apollo Endosurgery to market Orbera365 in the Kingdom of Saudi Arabia with its exclusive distribution partner, AL-Nozha Medical. The Orbera365 Managed Weight Loss System doubles the indwell period from a six to a 12 month treatment period.

First data published on post-approval US Orbera balloon system

Apollo Endosurgery has announced the first publication from the Orbera US post-approval multi-centre study. This multi-centre study presents early results of the clinical use of Orbera in a commercial setting and is the first study of Orbera within the US population outside of clinical trials. The results are based on 321 patients treated at eight centres (three academic and five private) after FDA approval in August 2015. The primary effectiveness outcomes of the study were percent total body weight loss (TBWL) at three, six, and nine months.

Apollo gains South Korean approval for the Orbera Balloon System

Apollo Endosurgery has announced that the South Korean Ministry of Food and Drug Safety’s (MFDS) has approved of its Orbera Intragastric Balloon System to assist adult patients who are overweight with a BMI> 27 in losing and maintaining weight.

OverStitch Sx Endoscopic Suturing System cleared by FDA

Apollo Endosurgery has announced that the FDA has provided 510k clearance for its OverStitch Sx, a new, full-thickness flexible endoscopic suturing system that will work on a broad range of single-channel flexible endoscopes. Flexible endoscopic suturing using Apollo’s current version of OverStitch is an important tool for both surgeons and gastroenterologists, but it is currently only compatible with a limited number of dual channel endoscopes and physicians without access to this specific capital equipment cannot leverage the benefits of endoscopic suturing.

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