Feature

Looking at the Pipeline in Bariatric Endoscopy

As the obesity epidemic continues to take hold of the United States, endoscopists have an opportunity to engage with this patient community and offer less invasive procedures for weight loss.

A lot of these devices can be used by a general endoscopist, not necessarily someone with advanced endoscopic training.

Currently, there are three endoscopic balloons available (ReShape Integrated Dual Balloon System, ORBERA Intragastric Balloon System and Obalon Balloon System), but other devices are expected to be released in the near future. Here are the top devices in the pipeline:

Reem Z. Sharaiha

Transpyloric Shuttle

The FDA studies for the transpyloric shuttle (BAROnova) recently finished and the final data should be presented later this year. This device is inserted endoscopically, creating a mobile barrier intended to fill the stomach faster, stay full for a longer period of time and delay gastric emptying. In the most recent study, the device was inserted for 1 year.

What we know from the company is that the study reached its endpoint in terms of safety and efficacy in this latest study. It should be another tool available to patients to lose weight.

Dissolving Balloon

Also underway are the FDA trials for the Elipse balloon (Allurion). Unlike the currently available balloons that are inserted and later removed, a patient would swallow the Elipse and it disintegrates 4 months later. As it is swallowable, this is not an endoscopy balloon but will appeal to some portion of your patients.

That trial is currently underway so we expect results in the next couple of years. That’s very exciting because the results from Europe look very promising.

Adjustable Balloon

Another balloon under FDA study is the adjustable balloon (Spatz), which has promising results in Europe and the Middle East but we will wait for results from the US trial.

The difference in this balloon from what’s out there is that you use the patient’s weight loss and discomfort level to dictate the amount of volume of fluid that you insert or remove into and from the balloon. The disadvantage is that you have to have multiple procedures.

Aspire Therapy

This is an endoscopically inserted percutaneous feeding tube that is used to aspirate food contents after a meal. Although people find the concept a lot to stomach, the results speak for themselves. In a randomized controlled trial (Pathway), the patients in the aspire group not only had sustained weight loss, but also demonstrated improvement in their eating habits. A recent trial compared Aspire therapy to surgical bypass, and the results demonstrate that aspire therapy achieve two-thirds of the weight loss of surgery with minimal adverse events. This therapy is a good option for patients who do not want to “diet”, but in order for them to have any weight loss, they have to methodically aspirate, thus forcing them to watch what they eat, and this will eventually change their eating habits, a true habitual device.

Endoscopic Suturing

Though the endoscopic suturing device (Overstitch; Apollo Endosurgery) is FDA approved for tissue apposition, it is not approved for weight loss. Currently, various retrospective studies have demonstrated safety and efficacy and the MERIT is a randomized control trial currently underway to look at using this device for endoscopic sleeve gastroplasty and its long-term weight-loss as compared to lifestyle modification.

Diabetes Devices

Other devices that are not approved in the U.S primarily treat diabetes but also have some effect on obesity and possibly fatty liver.

A magnetic device that works as an incisionless anastomosis system (GI Windows) uses two endoscopes to deploy two magnets at each end and cause a bypass in the patient. That bypass leads to improvement in the patient’s glycemic index and diabetes markers with some modest effect on weight loss. Early results have been promising and the manufacturer published on one trial last year. They’ve started doing more human trials in South America, so we await availability in the US in the next few years.

Then there is the Revita (Fractyl Laboratories) ablation system. This system ablates the duodenal mucosa to repopulate it with jejunal-like mucosa and that has shown promise to improve diabetes index and some early results in fatty liver. The Revita system is approved in Europe with early trial work expected to start in the U.S. soon.

Tips for Success

Most of these devices use tools the gastroenterologist uses daily, so the applicability may be wider than we think. The key things with any of these devices is the aftercare component is a big part of the procedure, especially if it’s a cash-paying procedure not covered by insurance. I highly suggest incorporating online or virtual entities such as BMIQ or Virtual Health Partners that can offer virtual nutrition follow up, which these patients will need to get the results they desire.

Additionally, depending on your practice environment – whether you are in a private practice ambulatory or hospital-based setting – it is vitally important to work within a multidisciplinary team. You need to have surgeons who are comfortable with what you’re doing not only to recruit patients, but also to support you in case of adverse events. Also, having endocrinologists on your team can alleviate the discomfort of prescribing medications if needed to achieve the best results.

To keep up on these devices and learn how to incorporate any of the existing technology into your practice, you can consult the ASGE and the Obesity Society, both offer hands-on courses throughout the year.

Disclosure: Sharaiha reports receiving grant/research support from Apollo and consulting for Apollo and Boston Scientific.

As the obesity epidemic continues to take hold of the United States, endoscopists have an opportunity to engage with this patient community and offer less invasive procedures for weight loss.

A lot of these devices can be used by a general endoscopist, not necessarily someone with advanced endoscopic training.

Currently, there are three endoscopic balloons available (ReShape Integrated Dual Balloon System, ORBERA Intragastric Balloon System and Obalon Balloon System), but other devices are expected to be released in the near future. Here are the top devices in the pipeline:

Reem Z. Sharaiha

Transpyloric Shuttle

The FDA studies for the transpyloric shuttle (BAROnova) recently finished and the final data should be presented later this year. This device is inserted endoscopically, creating a mobile barrier intended to fill the stomach faster, stay full for a longer period of time and delay gastric emptying. In the most recent study, the device was inserted for 1 year.

What we know from the company is that the study reached its endpoint in terms of safety and efficacy in this latest study. It should be another tool available to patients to lose weight.

Dissolving Balloon

Also underway are the FDA trials for the Elipse balloon (Allurion). Unlike the currently available balloons that are inserted and later removed, a patient would swallow the Elipse and it disintegrates 4 months later. As it is swallowable, this is not an endoscopy balloon but will appeal to some portion of your patients.

That trial is currently underway so we expect results in the next couple of years. That’s very exciting because the results from Europe look very promising.

Adjustable Balloon

Another balloon under FDA study is the adjustable balloon (Spatz), which has promising results in Europe and the Middle East but we will wait for results from the US trial.

The difference in this balloon from what’s out there is that you use the patient’s weight loss and discomfort level to dictate the amount of volume of fluid that you insert or remove into and from the balloon. The disadvantage is that you have to have multiple procedures.

Aspire Therapy

This is an endoscopically inserted percutaneous feeding tube that is used to aspirate food contents after a meal. Although people find the concept a lot to stomach, the results speak for themselves. In a randomized controlled trial (Pathway), the patients in the aspire group not only had sustained weight loss, but also demonstrated improvement in their eating habits. A recent trial compared Aspire therapy to surgical bypass, and the results demonstrate that aspire therapy achieve two-thirds of the weight loss of surgery with minimal adverse events. This therapy is a good option for patients who do not want to “diet”, but in order for them to have any weight loss, they have to methodically aspirate, thus forcing them to watch what they eat, and this will eventually change their eating habits, a true habitual device.

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Endoscopic Suturing

Though the endoscopic suturing device (Overstitch; Apollo Endosurgery) is FDA approved for tissue apposition, it is not approved for weight loss. Currently, various retrospective studies have demonstrated safety and efficacy and the MERIT is a randomized control trial currently underway to look at using this device for endoscopic sleeve gastroplasty and its long-term weight-loss as compared to lifestyle modification.

Diabetes Devices

Other devices that are not approved in the U.S primarily treat diabetes but also have some effect on obesity and possibly fatty liver.

A magnetic device that works as an incisionless anastomosis system (GI Windows) uses two endoscopes to deploy two magnets at each end and cause a bypass in the patient. That bypass leads to improvement in the patient’s glycemic index and diabetes markers with some modest effect on weight loss. Early results have been promising and the manufacturer published on one trial last year. They’ve started doing more human trials in South America, so we await availability in the US in the next few years.

Then there is the Revita (Fractyl Laboratories) ablation system. This system ablates the duodenal mucosa to repopulate it with jejunal-like mucosa and that has shown promise to improve diabetes index and some early results in fatty liver. The Revita system is approved in Europe with early trial work expected to start in the U.S. soon.

Tips for Success

Most of these devices use tools the gastroenterologist uses daily, so the applicability may be wider than we think. The key things with any of these devices is the aftercare component is a big part of the procedure, especially if it’s a cash-paying procedure not covered by insurance. I highly suggest incorporating online or virtual entities such as BMIQ or Virtual Health Partners that can offer virtual nutrition follow up, which these patients will need to get the results they desire.

Additionally, depending on your practice environment – whether you are in a private practice ambulatory or hospital-based setting – it is vitally important to work within a multidisciplinary team. You need to have surgeons who are comfortable with what you’re doing not only to recruit patients, but also to support you in case of adverse events. Also, having endocrinologists on your team can alleviate the discomfort of prescribing medications if needed to achieve the best results.

To keep up on these devices and learn how to incorporate any of the existing technology into your practice, you can consult the ASGE and the Obesity Society, both offer hands-on courses throughout the year.

PAGE BREAK

Disclosure: Sharaiha reports receiving grant/research support from Apollo and consulting for Apollo and Boston Scientific.