Ethicon Endo-Surgery, Inc. announced the U.S. Food and Drug Administration (FDA) qualified all for marketing the REALIZE(TM) Adjustable Gastric Band, a surgical jolt in for substance markdown and progress surrounded by chubbiness associated proviso terms, such in place of posture 2 diabetes, in individuals predicament from morbid obesity.

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In the multi-center U.S. clinical commotion of 276 patients with the REALIZE Band, patients who completed the three-year U.S. clinical trial (n2 gone astray an be unchanging to of 42.8 percent of their extra article weight. Thirty-five percent of patients who completed the three-year trial lost 50 percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The maximum traditionally story adverse dealings after surgery during the U.S. clinical trial be nausea, vomiting, constipation and gastroesophageal reflux (GERD). Only nine (3.3 percent) patients weathered a bookish adverse thing that be considered unanticipated and related to the REALIZE Band.

“This rigorous clinical trial show patients using the REALIZE Band experienced indicative weight harm in the original year, which remain become ever-present completed three years,” said Ed Phillips, MD, FACS, principal investigator in the REALIZE Band clinical trial and Director of the Center for Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center in Los Angeles.

“This etiquette, multiparty with the proper backing complicated and a commitment to dietetic and lifestyle change after surgery backing these patients complete long-term weight loss and improvement in repetitive obesity-related conditions.” In the REALIZE Band clinical trial, patients reported improvements in many aspect of their characteristic of duration mutually with well again prevailing health one year after surgery. Significant improvement in animation, psychosomatic health and national running was reported at three years after surgery, and reduction in in the flesh dull pain and increased gift to complete next to a daily perception and toil accomplishments three years after surgery were also reported.

“Obesity is a serious bug, and as a guests we’re committed to providing greater than products to address this unanimous epidemic; we tools out bariatric solution that can help population realize their health aspiration and playing longer and well again live regardless of which surgical resort may be accurately for them,” said Kevin Lobo, president, Ethicon Endo-Surgery, U.S. “With the confirmation of the REALIZE Band, Ethicon Endo-Surgery is the only worldwide healthcare company to provide a complete breadth of bariatric surgical solutions to surgeons and their patients.” About The REALIZE Band The REALIZE Band, which is market belittle than the heading Swedish Adjustable Gastric Band (SAGB) out-of-doors the U.S., have be commercially at liberty outside the U.S. since 1996 and has been previously own via more than 100,000 patients worldwide to help manage their weight.

In a gastric group procedure with the REALIZE Band, a like velvet, adjustable silicone band is wrap articulate the front to fabricate two chamber — a stunted upper stomach with a moderate heavens to the lower stomach. After the procedure, the upper stomach can only hang on nearly four ounces of stores, which precincts food intake, make patients love full aloft faster and longer, and lagging digestion.

Once the band is in lock, surgeons sticking together agent the REALIZE Injection Port to the abdominal wall underneath the crust. Using the REALIZE Injection Port Applier, this can be completed in smaller number than a tiny, thereby decreasing juncture under anesthesia. The REALIZE Injection Port allows doctors to inject or delete saline to tighten or unambiguous the band. The tighter the band, the more in the blink of an eye the upper stomach fill up and the less food a human man can drink. Adjustments be made periodically base on the patient’s special desires.

About Bariatric Surgery According to the American Society for Metabolic & Bariatric Surgery (ASMBS), more than 15 million people in the U.S. suffer from morbid obesity and about 205,000 people are scheduled to have more than a few attach powerful of of bariatric surgery this year. The two most common procedures are gastric bypass and gastric banding. Most of these procedures are perform laparoscopically using small incision, which typically grades in less pain, a lesser amount of complications and quicker recouping from surgery relate to ordinary open surgery. Laparoscopic adjustable gastric banding (LAGB) is reversible, if judgmental.

According to two recent dignified run through sanctum published in the New England Journal of Medicine in August 2007, patients with morbid obesity who have bariatric surgery (including gastric banding, gastric bypass, and vertical banded gastroplasty) lost significant weight over the long-term and are less feasible to go to meet your maker from heart disease, diabetes and cancer seven to 10 years subsequent the procedure than those who fix into trial not have the operation(1-2). Another study published in the Annals of Surgery in 2004 showed the mortality rate from morbid obesity was reduced by 89 percent after bariatric surgery(3).

As with any surgery, within are instant and long-term complications and risk. Patients should consult with their doctors to question these risks and their surgical consequences. Individual tolerant results may oscillate and are not indicative of all outcomes.

About Ethicon Endo-Surgery, Inc.

Ethicon Endo-Surgery, Inc., an operating company of Johnson & Johnson, is a global troublemaker in minimally interfering and traditional surgical devices for bariatric surgery and many other county of surgery. The company develop and market advanced medical devices for minimally invasive and open surgical procedures. The company focus on procedure-enabling devices for the interventional diagnosis and nursing of conditions roughly and bariatric surgery, as economically as gastrointestinal health, plastic surgery, orthopedics, gynecology and surgical oncology.

More hearsay on the company can be found at For more information about the REALIZE Band pop in References 1 Sjostrom L, Narbro K, Sjostrom CD, et al. Effects of bariatric surgeryv on mortality in Swedish obese premise. N Engl J Med 2007; 357:741-52.

2 Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med 2007:357:753-61.

3 Christou NV, Sampalis JS, Liberman M, et al. Surgery Decreases Long- lease Mortality, Morbidity, and Health Care Use in Morbidly Obese Patients. Ann Surg 2004;240(3):416-424.

Ethicon Endo-Surgery, Inc.

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