The weight-loss device market has seen a lot of contenders enter the ring to battle the obesity epidemic in the U.S., but only a few have survived the final round of the fight. One contender still going strong, however, is a Southern California company with a non-surgical procedure that uses an integrated dual balloon system.
ReShape Medical (Clemente, California) submitted its pre-market approval (PMA) application to the FDA in mid-2014 for its device, which is backed by promising clinical trial data (Medical Device Daily, July 3, 2014). Richard Thompson, president/CEO of ReShape, told Medical Device Daily on Wednesday that the FDA process is going "very well" and that the company has maintained a cooperative relationship with the agency since it submitted its PMA application last year.
"We are at the last stages, I would say, of receiving the FDA's decision," Thompson said.
If the FDA approves the device, the company plans what Thompson termed a rational launch, making the device available on a limited basis initially. "We want to go out to a particular number of accounts and get them well established and successful using the product before we go very broadly with the product we can take what we've learned there and then expand," he said.
The ReShape device is the first dual balloon for non-surgical weight loss designed for people with a 30-40 body mass index (BMI). Results from the REDUCE US pivotal trial, presented in November during ObesityWeek 2014, showed that patients who underwent the ReShape procedure lost 2.3 times more excess weight at six months compared to control patients treated with diet and exercise alone. There were also significant and sustained improvements in co-morbidities and strong patient satisfaction, along with maintenance of two-thirds of the weight loss through 12 months of study follow up.
The ReShape procedure is designed to help patients lose weight and facilitate behavior change. The integrated dual balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months without any sutures or fixation to the body. Once in place, the balloon is inflated with saline and is designed to take up enough space in the stomach and help patients feel full sooner and eat smaller portions. The device is not intended to change or alter the patient's anatomy and is fully reversible.
While the stomach-filling balloons are in place, patients are counseled by healthcare professionals on nutrition, exercise, and behavior modification to help them develop a healthier lifestyle. The program continues for an additional six months after the balloon is removed to encourage new habits and lasting results, ReShape said. Both the insertion and removal procedures take about 15 minutes and are performed with the patient under conscious sedation. The device could go a long way towards bridging a very large gap of patients who are eligible for bariatric surgery but refuse to consider that as an option.
While there is currently no non-surgical device in this market in the U.S., Thompson noted that there is one other company that also has a balloon technology under FDA review. Apollo Endosurgery (Austin) acquired the Orbera intra-gastric balloon system from Allergan (Irvine, California) in late 2013.
Although both technologies involve inserting a balloon into the patient's stomach to fill up space, Thompson said there are significant physical differences between the two systems because Apollo's device is a single-balloon system as opposed to ReShape's dual-balloon system. He said single-balloon systems are limited in how much of the stomach they can fill by the width of the stomach, leaving a lot of volume left in the stomach for the patient to eat. With ReShape's dual-balloon approach, there are two balloons attached side by side on a flexible shaft so that together the balloons are able to fill up more volume, patients eat less, and the expectation would be greater weight loss. He noted, however, that there have not been any head-to-head studies comparing the two systems and that Apollo's data has not yet been made public.
Another advantage to using two balloons, Thompson said, is that they are able to better conform to the shape of the stomach. But more importantly is the safety advantage, he said, explaining that if a balloon deflates spontaneously there is a risk that it will migrate into the patient's intestine and create a dangerous obstruction that may result in surgery. With the ReShape system, however, if one balloon deflates prematurely, the second balloon would remain inflated and prevent the entire apparatus from migrating, Thompson said. As an added precaution, the saline that fills the two balloons contains a blue dye and patients are trained to report to their doctor if they see very dark urine, which could indicate a problem.
The ReShape device has been available in Europe since 2011. The REDUCE trial included 326 patients at eight U.S. sites that measured the safety and effectiveness of the procedure as an adjunct to diet and exercise. Patients undergoing the ReShape procedure lost more than twice as much weight as the sham-controlled subjects who received diet and exercise alone, the company noted.
As he has pointed out in previous conversations with MDD, Thompson said that fear of surgery is only part of the reason so many patients decline the existing surgical weight-loss options. Many patients simply want to feel like they are solving the problem on their own, rather than feel like they are giving up by having surgery. For those patients, ReShape could be the help they are looking for without any stigmas they might have regarding surgery.
Not only has the ReShape device shown promise clinically, Thompson said the company conducted patient satisfaction surveys at the end of the REDUCE trial and 67% of participants said they would have the ReShape procedure again and 77% would recommend it to a friend.
About four years ago, another California company fighting for a place in the bariatric device market, Satiety (Palo Alto, California) was forced to throw in the towel due to weak trial results for its Trans-oral Gastroplasty (TOGA) procedure (MDD, May 17, 2011). The TOGA procedure involved the creation of a gastric sleeve so small that when even little amounts of food entered and pushed against its wall, the patient felt a sensation of fullness.