After the recent authorization by the American drug agency Fda for the marketing of Apollo Esg * in the treatment of obesity, comes the publication of the Merit study (Multi-center Esg Randomized Interventional Trial), a reference work for the efficacy and safety of the ESG procedure of endoscopic vertical gastroplasty. This was announced by Apollo Endosurgery, world leader in the production of minimally invasive medical devices for gastrointestinal and bariatric interventions, in a note released today. Esg endoscopic vertical gastroplasty – explains the company – today represents a less invasive option for thousands of patients suffering from obesity. Obesity is taking shape as a real chronic disease and its management requires a complex and multidisciplinary approach. Bariatric surgery is the most successful treatment, but many patients prefer to avoid surgery due to its invasive nature and fear of complications. Esg is an incisionless procedure, which uses an endoscopic suturing system (OverStitch *) aimed at reducing the volume of the stomach and delaying its emptying, achieving lasting and clinically significant weight loss. The Merit multicentre randomized prospective clinical trial involved 9 US gastroenterology and bariatric surgery centers for 52 weeks – including the Mayo Clinic, the University of Texas at Houston and Weill Cornell Medicine – and 152 subjects with body mass index (Bmi ) greater than or equal to 30 kg / m² and less than or equal to 40. The main results show that, in patients undergoing ESG, there was a loss of 49.2% of excess body weight (Ewl) 12 months after intervention, compared to 3.2% in the control group. In the responder group, there was an average loss of 16.3% of total body weight (Tbwl) and 68.3% of these patients maintained at least 25% body weight loss at 104 weeks post-treatment. intervention. The study also highlights the improvement in quality of life, eating behaviors and depression in the people treated. Three post-ESG patients (2.0%) experienced serious adverse events related to the device or procedure, all of which were resolved and did not require intensive care or surgery. “The Merit study finally reveals the important thing. opportunity, offered both to healthcare professionals who perform endoscopic gastroplasty and to patients, to have a safe and effective procedure for the treatment of I and II degree obesity – commented Giovanni Galasso, Head of Gastroenterology and Digestive Endoscopy Service, Pineta Grande Hospital di Castel Volturno (Caserta) – Not only that, this method has a really significant impact on the comorbidities associated with obesity: hypertension, diabetes, sleep apnea, metabolic syndromes, oncological diseases “. The publication of the Merit study on ‘The Lancet’ – continues the note – is added to more than 250 publications and abstracts that report the results of over 10 thousand patients undergoing procedures re Esg and arrives immediately after another milestone reached by the Apollo Endosurgery procedures, namely the De Novo authorization of the Food and drug administration). The green light from the US regulatory agency, in fact, concerned not only Apollo ESG, but also Apollo Revise *, an endoscopic procedure for the revision of a previous gastric bypass, which, like ESG, can be performed without incisions or scars. These are the first and only FDA-cleared devices for endoscopic vertical gastroplasty and endoscopic revision bariatric surgery. Revision bariatric surgery procedures are today the fastest growing segment in this sector. “Obesity is a chronic, relapsing and degenerative disease that affects a huge number of patients worldwide, of which only 1% arrives. at the operating, surgical or endoscopic table – remembers Ivo Boškoski, Md, Phd, Assistant Professor of Gastroenterology Agostino Gemelli University Hospital Foundation Irccs of Rome, Catholic University of the Sacred Heart – Center for Endoscopic Research Therapeutics and Training (Certt) – What is missing, for a long time now, they have been minimally invasive endoscopic procedures for the treatment of obesity. At Policlinico Gemelli we have been carrying them out since 2014 in the form of protocols or local approvals: we are really happy that today the FDA approval for vertical gastroplasty has arrived endoscopic, and confident that this will soon pave the way for approval in Europe and Italy. It is important to note – ag the specialist arrives – how patients suffering from a low degree of obesity still require treatment, since the patient who today has for example 31-32 as a Bmi tomorrow could have 35, 36 and then 40, with a strong impact on the system national health. Furthermore, the early treatment of obesity, both nutritionally and minimally invasive endoscopy, is particularly important to prevent degenerative diseases that derive from obesity “. Apollo Esg and Apollo Revise – the note continues – add to the growing portfolio of endoscopic solutions for weight loss in obese patients. Esg systems are designed to be used by qualified gastroenterologists or surgeons to facilitate weight loss in obese adult patients with a BMI between 30 and 50 kg / m2, which have failed to lose weight or maintain weight with more conservative measures. Revise systems are intended for use by qualified gastroenterologists or surgeons who perform bariatric procedures to facilitate weight loss in obesity adult patients with a Bmi between 30 and 50 , as a revision of a previous bariatric procedure.Some studies have shown that after 10 years, patients Patients undergoing gastric bypass have regained on average 20-30% of the weight they initially lost. “The authorization of these new endoscopic systems, coupled with the publication of the Merit study in such an influential and impactful journal as The Lancet – says Chas McKhann, president and CEO of Apollo – represent a strong signal of the opportunity we have at Apollo to expand therapeutic options to treat obesity and metabolic disorders and make a real difference in the fight against the obesity epidemic. “
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