Organic Architecture

A Stent for Obesity Progressing into Larger Trials

Making progress with medical devices to treat obesity is a tedious business. And it comes with many ups and downs. But with a more reasonable pathway for FDA approvals these days, more entrepreneurs are trying to advance their ideas. In the latests news, the folks developing a hunger-curbing stent for obesity have raised $2.1 million to help fund clinical trials for approval.

The Full Sense Device

The device is a modified esophageal stent that’s placed where the esophagus meets the stomach.  It’s designed to signal satiety by putting pressure on the gastric cardia. So far, we have only limited, encouraging data on clinical efficacy presented at professional meetings. These preliminary data suggest that results might be comparable to other devices, such as gastric balloons.

The real challenge to date has been to refine this device’s design to ensure that safety issues don’t crop up and destroy its potential. With that task more or less complete, the developers now think they’re ready to scale up their clinical trials.

Slow Going for a Host of New Devices

Bringing a new device to market for obesity is no small feat. A recent review in Gastrointestinal Endoscopy identified more than a dozen new technologies. Some, like gastric balloons, have approval and are gaining some limited use. Many, like the Full Sense Device, are plodding toward a filing.

For the devices that gain approval, the challenge comes with figuring out how to fit these short-term therapies into the management of a chronic disease. The only notable exception is the vagal nerve bloc device, known as vBloc. Researchers published two-year outcomes with vBloc therapy earlier this year.

We don’t expect any of these devices to produce miracles. But they can become tools for helping a person with obesity find a way to better health.

Click here and here for more on the Full Sense device. Click here for a recent review of endoscopic devices for obesity.

Organic Architecture, photograph © SBA73 / flickr

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May 1, 2017