With U.S. commercialization okay of a new adjustable gastric band — an implantable device intended to treat morbid obesity — a second company has entered the country’s gastric banding market.

Ethicon Endo-Surgery (Cincinnati) last week reported FDA approval for its Realize Adjustable Gastric Band, indicated for people 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, the company said.

The company reported submitting an application for FDA approval of the band in April (Medical Device Daily, April 11, 2007).

Ethicon, a business of Johnson & Johnson (J&J; New Brunswick, New Jersey), joins Allergan (Irvine, California) in an effort to entice morbidly obese patients to use gastric banding, a less-invasive alternative to bariatric surgery. The FDA cleared Allergan’s Lap-Band in 2001 (MDD, June 7, 2001).

In the 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 is able to hold only 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, which can be done in less than a minute, according to the company. 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, the company said.

In effect, the Realize “works like the Lap Band,” Ed Phillips, MD, principal investigator in the multi-center U.S. trial with the Realize Band, told Medical Device Daily.

Phillips, director of the Center for Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center (Los Angeles), said comparing the two gastric bands is a bit like comparing a Ford to a Chevy, with slight differences in the way the two devices are constructed. Now that both bands are available though, he said there will probably be some head-to-head trials done to compare the two.

Larry Biegelsen, a med-tech analyst for Wachovia Capital Markets, in a research note said that Wachovia expects the global banding market to reach $1 billion in 2011, up from $320 million this year. Biegelsen said that J&J is expected to gain 50% of the market share by 2011.

Factors that should help the U.S. market growth stay robust, according to Biegelsen’s research note, include the “vastly underpenetrated” U.S. population of bariatric surgery candidates. According to Biegelsen, less than 1% of the 15 million Americans who would qualify for bariatric surgery have it done.

The note says that increases penetration into the obese population sector should be driven by increased awareness of surgical options for patients through Allergan’s and J&J’s increased marketing efforts; increased insurance coverage; the potential for expanded indications; and recent positive outcomes data.

In the Realize Band trial, the 228 patients who completed the three-year trial lost an average of 42.8% of excess body weight, 35% lost at least 50% of excess body weight and 10.5% lost 75% or more of excess body weight, Ethicon said.

The most commonly reported adverse events after surgery during the trial were nausea, vomiting, constipation and gastroesophageal reflux, known as GERD. Nine patients, or 3.3%, experienced a serious adverse event related to Realize Band use that was considered “unanticipated.”

“It takes about three years to lose the maximum weight [with gastric banding],” Phillips said, compared to gastric bypass, which takes about 18 months. He added that the gastric band is a “tool” that also requires patient compliance.

“This rigorous clinical trial showed patients using the Realize Band experienced significant weight loss within the first year, which remained steady over three years,” Phillips said. “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 trial, patients reported improvements in various quality-of-life factors, including better general health one year after surgery, the company noted. Significant improvements in vitality, mental health and social functioning were reported at three years after surgery, along with reduction in bodily pain and increased ability to complete daily activities.

The Realize Band, to be marketed as the Swedish Adjustable Gastric Band outside the U.S., has been available overseas since 1996 and has been used by more than 100,000 patients worldwide to help manage their weight, Ethicon said.

But a changing trend in bariatric surgery in Europe could spell trouble for the U.S. gastric banding market, Biegelsen noted.

“Our contacts indicate that gastric banding is falling out of favor in key markets, including Germany and Switzerland, due to long-term complications,” Biegelsen said. “The Lap-Band has been available in [Europe] about 10 years longer than in the U.S., and we understand that complications that emerge at four to five years post-op have discouraged some [European] surgeons from continued use. Surgeons are moving to more invasive procedures including gastric bypass, gastric sleeving, and duodenal switch.

“This is the largest risk to our U.S. banding forecasts, given that U.S. surgeons are approaching five-year follow-up over the next few years.”

Biegelsen said that gastric sleeving might emerge as a threat to the banding market in about three years when it receives insurance coverage.

While gastric sleeving is more invasive than banding and targeted for the extremely obese, U.S. and European doctors are optimistic about it because of its improved weight loss profile of 40% to 60% at one to two years, Biegelsen said. Gastric sleeving also has lower comparable side effects to banding, he noted.

Because Ethicon plans to launch Realize in December, Biegelsen said, Wachovia analysts shifted $2 million in projected 4Q sales from Allergan to J&J.

“However, we increased our overall market forecasts and increased our Lap-Band estimates, beginning in 2008, with the modest earnings impact flowing to EPS,” Biegelsen said.