Ethicon Reports Major Progress On Multi-Year Initiative To Fill Clinical And Economic Evidence Gaps And Expand Access To Bariatric Surgery

LONDON, Aug. 30, 2017 /PRNewswire/ -- Ethicon*, part of Johnson & Johnson Medical Devices Companies**, and a leader in bariatric surgery for more than 15 years, is continuing to push the boundaries of innovation in bariatric surgery both inside and outside the operating room.  At the 22^nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Diseases (IFSO 2017), the company announced major progress in its multi-year, multimillion-dollar global initiative called "Project Game Changer," to close evidence gaps, reduce clinical and economic barriers and expand patient access to the surgical treatment of obesity and related diseases and conditions including type 2 diabetes, hypertension and orthopedic issues.

"Groundbreaking clinical and economic studies, major treatment guidelines and real world evidence have contributed to the transformation of bariatric surgery from what was once considered by some to be either cosmetic or high risk to an effective lifesaving operation whose benefits go far beyond weight loss," said Michael del Prado, Company Group Chairman, Ethicon.

The worldwide prevalence of obesity more than doubled between 1980 and 2014. According to the World Health Organization (WHO), more than 1.9 billion adults were overweight in 2014. Of this group, more than 600 million have obesity.ⁱ In the United States, more than 2 in 3 adults are overweight or have obesity, and about 1 in 13 are considered to have extreme obesity.ⁱⁱ

For the Game Changer Initiative, Ethicon is focusing its research and evidence generation efforts on the safety^# and effectiveness of bariatric surgery on reducing obesity, and obesity-related diseases such as type 2 diabetes, heart disease, and orthopedic conditions, as well as the treatment's impact on healthcare costs. Several studies have already been published in peer reviewed journals and many more are underway.

Ethicon's approach to research will be featured in a panel discussion at IFSO 2017, where leading researchers will share their perspectives on how a mix of clinical, pre-clinical, and real world evidence studies are helping to drive the future of bariatric surgery. Separately, early research findings will be shared from Ethicon-funded multi-center retrospective and prospective trials of gastric bypass in China.

"A wide range of evidence guides innovation, adoption of procedures and everyday treatment decisions. We are committed to working with the bariatric community to advance the specialty and expand access for the benefit of patients everywhere. Significant progress has been made, but much work is left to do," said Elliott Fegelman, MD, Therapeutic Area Lead for Metabolics at Johnson & Johnson Innovation.

Clinical Trials and Guidelines Shape Bariatric Surgery for Obesity and Type 2 Diabetes
For Ethicon, the focus on obesity and type 2 diabetes is not new. Through the years, the company has been a sponsor of randomized clinical trials including the landmark STAMPEDE study, whose five-year outcomes were published in The New England Journal of Medicine (NEJM) earlier this year. The study showed bariatric surgery with intensive medical therapy is a better long-term treatment than intensive medical therapy alone for obese patients with uncontrolled type 2 diabetes.ⁱⁱⁱ

The three-year outcomes from STAMPEDE, also published in NEJM in 2012, were cited in global clinical guidelines from international diabetes organizations, that for the first time, included bariatric and metabolic surgery as a standard treatment option for people with diabetes, including those who are mildly obese and fail to respond to conventional treatment. Ethicon provided support for the Second Diabetes Surgery Summit (DSS-II), the international consensus conference that developed the guidelines that were endorsed and adopted by 45 medical professional societies including the European Association for the Study of Diabetes (EASD), International Diabetes Federation (IDF), American Diabetes Association (ADA), International Federation of Surgery of Obesity (IFSO), and the American Society for Metabolic and Bariatric Surgery (ASMBS).^iv

The work of STAMPEDE will continue in ARMMS (Alliance of Randomized trials of Medicine versus Metabolic Surgery in type 2 diabetes), a study that combines STAMPEDE and three other trials to assess the impact of surgery for up to 10 years. This ongoing research increases awareness and access to bariatric surgery for improved patient outcomes and quality of life. Studies are also underway on metabolic surgery in Asian Indian populations, on the mechanism of action of bariatric surgery, and on the impact of bariatric surgery on diabetic nephropathy.

Real World Evidence Matters
Ethicon collects and analyzes real world evidence from actual clinical practice to better understand the impact and value for specific markets and populations.  Studies conducted in several regions throughout the world have shown bariatric surgery results in a reduction of healthcare costs and hospitalization and less reliance on medications for diabetes, dyslipidemia, and hypertension, because of weight loss that leads to disease improvement or remission.

The Next Frontier for Evidence Generation
Ethicon is actively investigating the impact of bariatric surgery on other obesity-related diseases through studies such as SWIFT, an Ethicon-funded, multi-center, case-matched control study, which seeks to understand if weight loss as a result of bariatric surgery can delay the need for a total knee replacement or improve function after total knee replacement. The company is also conducting a randomized controlled clinical trial of gastric bypass in patients with obesity and poorly controlled hypertension and in obese patients with diabetic nephropathy.

Ethicon Technology Solutions on Display at IFSO 2017
At IFSO 2017, Ethicon is showcasing the ECHELON FLEX™ GST System and the data behind it. This surgeon-controlled powered stapler and reload system is designed to enable precision stapling performance with uniform staple line formation across the widest range of tissue thickness – making it ideally suited for bariatric surgery. A real-world analysis of hospital discharge data from the Premier Perspective^® Hospital Database has shown that the use of Powered ECHELON FLEX™ is associated with significant clinical and economic benefits. These include 47% lower rate of bleeding complications^v, 14% shorter operating room time^vi, and 13% lower overall hospital costs^vii when compared to the Medtronic Endo GIA™ with Tri-Staple™ Technology and other manual staplers.

About Ethicon
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.
^# All surgery presents risk.  Please consult with your doctor.

ⁱ http://www.who.int/mediacentre/factsheets/fs311/en/
ⁱⁱ https://www.niddk.nih.gov/health-information/health-statistics/overweight-obesity
ⁱⁱⁱ http://www.nejm.org/doi/full/10.1056/NEJMoa1600869
^iv http://care.diabetesjournals.org/content/39/6/861
^v Use of Ethicon powered staplers is associated with fewer bleeding / transfusion complications (1.61%) compared to Medtronic non-powered staplers (3.05%), p=0.010, in laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass procedures. Based on retrospective analysis of 21,466 cases from the Premier Hospital Data Base.
^vi Ethicon powered staplers (133 minutes) compared to Medtronic non-powered staplers (154 minutes), p<0.011, in laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass procedures. Based on retrospective analysis of 21,466 cases from the Premier Hospital Data Base.
^vii Ethicon powered staplers ($12,261) compared to Medtronic non-powered staplers ($14,038), p=0.022, in laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass procedures. Based on retrospective analysis of 21,466 cases from the Premier Hospital Data Base.

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