Ethicon Endo-Surgery, Inc. Provides New Option To Treat Morbid Obesity
CINCINNATI, Sept. 28 /PRNewswire/ -- Ethicon Endo-Surgery, Inc.
announced today the U.S. Food and Drug Administration (FDA) approved for
marketing the REALIZE(TM) Adjustable Gastric Band, a surgical implant for
weight reduction and improvement in obesity-related health conditions, such
as type-2 diabetes, in individuals suffering from morbid obesity.
The REALIZE Band is an innovative device intended for use in weight
reduction for patients with morbid obesity and is indicated for individuals
with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35
kg/m2 with one or more co-morbid conditions. It is for use in morbidly
obese adult patients who have failed more conservative weight-reduction
alternatives, such as supervised diet, exercise and behavior modification
programs.
In the multi-center U.S. clinical trial of 276 patients with the
REALIZE Band, patients who completed the three-year U.S. clinical trial
(n=228) lost an average of 42.8 percent of their excess body 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 most commonly reported adverse events after
surgery during the U.S. clinical trial were nausea, vomiting, constipation
and gastroesophageal reflux (GERD). Only nine (3.3 percent) patients
experienced a serious adverse event that was considered unanticipated and
related to the REALIZE Band.
"This rigorous clinical trial showed patients using the REALIZE Band
experienced significant weight loss within the first year, which remained
steady over 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 procedure, combined with the proper support system
and a commitment to dietary and lifestyle changes after surgery helped
these patients achieve long-term weight loss and improvement in many
obesity-related conditions."
In the REALIZE Band clinical trial, patients reported improvements in
various aspects of their quality of life including better general health
one year after surgery. Significant improvement in vitality, mental health
and social functioning was reported at three years after surgery, and
reduction in bodily pain and increased ability to complete daily and work
activities three years after surgery were also reported.
"Obesity is a serious disease, and as a company we're committed to
providing more than products to address this worldwide epidemic; we provide
bariatric solutions that can help people realize their health goals and
live longer and healthier lives regardless of which surgical option may be
right for them," said Kevin Lobo, president, Ethicon Endo-Surgery, U.S.
"With the approval of the REALIZE Band, Ethicon Endo-Surgery is the only
global healthcare company to provide a complete range of bariatric surgical
solutions to surgeons and their patients."
About The REALIZE Band
The REALIZE Band, which is marketed under the name Swedish Adjustable
Gastric Band (SAGB) outside the U.S., has been commercially available
outside the U.S. since 1996 and has been used by more than 100,000 patients
worldwide to help manage their weight.
In a gastric band procedure with the REALIZE Band, a soft, adjustable
silicone band is wrapped around the stomach to create two chambers -- a
small upper stomach with a narrow opening to the lower stomach. After the
procedure, the upper stomach can only hold about four ounces of food, which
limits food intake, makes patients feel full faster and longer, and slows
digestion.
Once the band is in place, surgeons attach the REALIZE Injection Port
to the abdominal wall underneath the skin. Using the REALIZE Injection Port
Applier, this can be completed in less than a minute, thereby decreasing
time under anesthesia. The REALIZE Injection Port allows doctors to inject
or remove saline to tighten or loosen the band. The tighter the band, the
more quickly the upper stomach fills up and the less food a person can eat.
Adjustments are made periodically based on the patient's individual needs.
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 expected to have some form of bariatric
surgery this year. The two most common procedures are gastric bypass and
gastric banding. Most of these procedures are performed laparoscopically
using small incisions, which typically results in less pain, fewer
complications and quicker recovery from surgery compared to traditional
open surgery. Laparoscopic adjustable gastric banding (LAGB) is reversible,
if necessary.
According to two recent landmark studies 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 likely to die from heart disease, diabetes and cancer seven to 10
years following the procedure than those who did 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, there are immediate and long-term complications
and risks. Patients should consult with their doctors to discuss these
risks and their surgical outcomes. Individual patient results may vary 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 leader in minimally invasive and traditional surgical devices
for bariatric surgery and many other areas of surgery. The company develops
and markets advanced medical devices for minimally invasive and open
surgical procedures. The company focuses on procedure-enabling devices for
the interventional diagnosis and treatment of conditions in general and
bariatric surgery, as well as gastrointestinal health, plastic surgery,
orthopedics, gynecology and surgical oncology. More information on the
company can be found at http://www.ethiconendo.com. For more information about the
REALIZE Band visit http://www.realizeband.com.
1 Sjostrom L, Narbro K, Sjostrom CD, et al. Effects of bariatric surgery
on mortality in Swedish obese subjects. 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-
term Mortality, Morbidity, and Health Care Use in Morbidly Obese
Patients. Ann Surg 2004;240(3):416-424.
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