USGI Medical Receives FDA Approval to Launch Head-to-Head Pivotal Study to Determine Safety, Effectiveness of Incisionless, Endoscopic Weight Loss Procedure
Among the largest multicenter, randomized, blinded, sham-controlled studies of an endoscopic approach to primary bariatric surgery ever undertaken
Data from earlier European studies show investigational procedure led to 62% excess weight loss at 12 months
SAN CLEMENTE, Calif. – October 9, 2013 – USGI Medical, Inc., the incisionless surgery company, has obtained conditional approval of its investigational device exemption (IDE) application from the U.S. Food and Drug Administration (FDA) to launch what the company believes to be the largest multicenter, randomized, sham-controlled study of an endoscopic procedure for weight loss ever conducted. The company plans to enroll approximately 350 subjects at up to nine centers across the U.S.
“Although published data show significantly superior weight loss results from bariatric surgery than from diet and exercise alone, a major open or laparoscopic operation still poses risks and longer recovery times, and surgery is not right for every patient,” said Thomas E. Lavin, MD, FACS, FASMBS, founder of The Surgical Specialists of Louisiana and an investigator in the study, known as the ESSENTIAL™ Trial. “Surgery for weight loss has been studied with positive results, but this will be one of the first major trials to prospectively compare the effectiveness of an endoscopic procedure against a sham procedure plus diet and exercise. Based on preliminary studies conducted in Europe, we believe that this new approach may help patients feel full sooner during meals, improving satiety and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight.”
Physicians participating in the study will use USGI Medical's g-Cath EZ™ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal. The g-Cath, which is used extensively for general, non-obesity indications, is the first endoscopic suturing technology proven to create a durable, healed fold in the stomach.
The incisionless outpatient procedure has been performed on over 2,000 patients, mostly in Europe, where it is known as “POSE.” The procedure is performed entirely through the mouth without any incisions through the abdomen. Many patients have returned to work without any bandages or signs of surgery within two to three days.
“If the data are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they’ve struggled to lose weight with diet and exercise, but aren’t prepared to accept the risk of traditional bariatric surgery,” Dr. Lavin added.
“The start of the ESSENTIAL Trial represents a significant milestone for USGI Medical and endoscopic approaches to weight loss,” said John Cox, Chief Operating Officer of USGI Medical. “Our efforts to support this study underscore our excitement about the potential of our technology and our commitment to patient safety and outcomes. We look forward to working with many of the country’s leading bariatric surgeons and advanced endoscopists, both at top academic medical institutions and well-respected private centers, to enroll patients in this study. Based on our experience to date, we believe our new incisionless approach to treating obesity may offer promise to patients who have struggled to lose weight through diet and exercise.”
Results of European Studies of POSE Recently Announced
Physicians from Spain reported results of two studies showing the positive outcomes and physiological effects of the POSE procedure at the 18th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO) in Istanbul this past August.
Román Turró, M.D., reported results of his team’s POSE experience at the GI Endoscopy Department at the Centro Medico Teknon, Barcelona. Prospective, institutional ethics-approved data collection began in February 2011 and included results from 137 consecutive procedures performed through July 2013. The first 22 patients who had been followed for 12 months post- procedure at the time of the presentation achieved average excess weight loss of 62% and total body weight loss of 19%.
Importantly, initial safety data were favorable for POSE as well. Of the 137 patients, none were hospitalized with a surgical intervention after undergoing POSE. One patient developed an infection that was treated with antibiotics and two patients suffered intra-gastric bleeding, which was treated endoscopically. The average age of patients included in the safety analysis was 42.8 years and the average body mass index (BMI) was 36.9 at the time of the procedure. Females accounted for 74% of the patients
Endoscopies on a subset of these patients also confirmed that the suture anchors remained in place in the stomach 12 months after the procedure.
Separately at IFSO, Silvia Delgado-Aros, MSc, MD, PhD, a member of the Neuro-Enteric Translational Science (NETS) Research Group at the Institut Hospital del Mar d’Investigacions Mèdiques in Barcelona, presented physiologic findings showing that POSE led to weight loss, a sustained reduction in caloric intake, normalization of blood sugar levels and improved feelings of fullness and satiety triggered by an improved gut peptide response to food. In this controlled study, patients followed for 15 months reported mean excess weight loss of 63.7%
For additional details about the ESSENTIAL Trial™, please visit ClinicalTrials.gov
CAUTION: Investigational Device. Limited by United States law to investigational use. The safety and effectiveness of the g-Cath for weight loss has not been established.
On June 18, 2013, the American Medical Association adopted policy that recognizes obesity as a disease requiring a range of medical interventions to advance obesity treatment and prevention. The American Heart Association (AHA) estimates that 78.4 million Americans age 20 and over are obese (with a BMI of 30.0 kg/m2 and higher). If current trends in the growth of obesity continue, total healthcare costs attributable to obesity could reach $861 to $957 billion by 2030, which would account for 16% to 18% of U.S. health expenditures, the AHA predicts.
About USGI Medical
USGI Medical is committed to the development of technologies to enable Incisionless Surgery – the treatment of diseases through the natural passageways of the body. USGI’s Incisionless Operating Platform™ provides surgeons the operating platform and specialized tools they need to perform surgery through a patient’s mouth or other natural orifices, reducing the need for external incisions into the abdomen. Importantly, USGI has demonstrated the capability to reliably and durably suture GI tract tissue without an incision. Operating through the body’s natural orifices offers promise for less pain, shorter hospital stays, reduced risk of wound infection and no external scars – and is rapidly becoming an option sought after by patients and healthcare providers. USGI offers surgeons and gastroenterologists the tools they need to offer millions of potential patients a less invasive surgical option. www.usgimedical.com
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