2014 – For GI tech interventions, it was a very good year
Endoscopy wasn’t the only subspecialty to bask in this new sunny clime. In January, the FDA approved St. Paul–based EnteroMedics’ Maestro system – a neuromodulatory approach to weight loss for obese adults. Maestro is an implanted vagus nerve stimulator that modulates neural signaling, controlling gastric emptying. It also seems to affect hunger signaling, Dr. Pasricha said.
Despite Maestro’s unique method of action – and the fact that it’s the first new weight-loss device approved since 2007 – EnteroMedics’ bottom line hasn’t surged, yet. But it may be too early to look for the impact and in general the outlook for nonsurgical approaches to obesity remains bullish.
Dr. Pasricha reminded the audience about some very basic core principles for successful innovation. “To succeed, you have to have two of three key things. You have to fill an unmet need. The intervention should be simple. And it should be effective.”
Since most GERD patients do fine on medical therapy, those interventions won’t succeed based on need alone. But endoscopic GERD treatments are simple and quite effective. Obesity, on the other hand, presents an enormous unmet need. But the current interventions – including Maestro – are far from simple. And efficacy hasn’t been completely confirmed yet, Dr. Pasricha said.
A couple of other obesity devices are in the works. Apollo Endosurgery (Austin) is focusing on the ORBERA single intragastric balloon. ReShape Medical (San Clemente, Calif.) reported positive data from its pivotal phase III trial of its own intragastric balloon. The device consists of two linked balloons, which the company maintains fit the stomach contours better than does a single balloon.
Over 6 months, patients treated with the dual balloon experienced a mean total body weight loss of 16% (about 17 kg). It seemed to impart some lasting benefit, as those who had continued nutritional counseling after removal maintained about 94% of their weight loss over 7 months of follow-up.
On the basis of these data, ReShape was able to secure close to $7 million in private funding to continue work on the device.
“The great potential for balloon therapy is to make it easier for patients to enter the area of bariatric surgery,” Dr. Pasricha said. “They are not naturally drawn into surgery – they usually have to be pushed into it. But with balloon treatment, they are able to enter, and the threshold for more interventions is then much lower.”
