The Centers for Disease Control and Prevention reports that more than one-third of U.S. adults (35.7%) are obese. Because obesity is associated with so many other health problems, such as heart disease and diabetes, the topic has drawn a great deal of attention at industry gatherings, including the Cleveland Clinic Medical Innovation Summit last month where the clinical focus was on obesity, diabetes, and the metabolic crisis.
But recognizing that obesity is a problem is only half the battle. Finding a solution to this problem, which affects both children and adults and creates an overwhelming drain on healthcare resources, seems to be easier said than done.
“We just need one winner,” Philip Schauer, MD, the director of Bariatric & Metabolic Institute at the Cleveland Clinic, told me at a networking event during the Medical Innovation Summit.
The bariatric device space came close to declaring a winner a few years ago with a technology that is no longer in development. Satiety (Palo Alto, California) had developed the Trans-oral Gastroplasty, or TOGA, procedure. That 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. Satiety got as far as completing a pre-market approval study in the U.S. and the TOGA procedure even landed on the Cleveland Clinic’s prestigious Top 10 list of innovations expected to make a big impact on healthcare in 2011. But when less-than stellar weight loss results came in, the company was shut down.
All hope is not lost, however. I recently wrote about ReShape Medical (San Clemente, California), a company trying to bring a non-surgical weight-loss device to the U.S. market. ReShape reported earlier this month that its REDUCE trial for its ReShape Duo Intragastric Balloon met its primary efficacy endpoints. That makes ReShape the first company to meet its primary efficacy endpoints in a U.S. randomized, sham-controlled pivotal trial for weight loss.
ReShape plans to submit a pre-market approval application to the FDA in the second quarter of 2014. Richard Thompson, president/CEO of ReShape Medical, told me there was significant interest in participation in the study, which speaks to the clear need for a product like the ReShape Duo balloon. The balloon is endoscopically placed down the esophagus and into the stomach without requiring any incisions, sutures or fixation to the body. Once in place, the balloon is inflated with saline and designed to take up much of the stomach’s volume, causing patients to eat smaller portions and to feel full sooner. The device does not change or alter the patient’s anatomy, and is fully reversible. The balloon is removed after six months.
What I think is interesting about this procedure, aside from the incision-free aspect, is the fact that the device is intended to help patients achieve a healthy weight, but the patients are still expected to work with dietitians, doctors and nurses to learn healthy diet and exercise habits during and beyond the treatment period. 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.
Interestingly, Thompson pointed out that fear of surgery is only part of the reason so many patients decline the surgical weight loss option. 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.