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FDA Approves New Surgically-Implanted Device to Treat Obesity

FDA Approves New Surgically-Implanted Device to Treat Obesity

The Maestro Rechargeable System is surgically implanted and helps control feelings of hunger in subjects

The FDA has approved the use of the Maestro Rechargeable System as a method of obesity treatment.

The U.S. Food and Drug Administration has approved a new device to treat obesity called the Maestro Rechargeable System from EnteroMedics Inc, reports Reuters.

The device is surgically implanted and works by interrupting the nerve pathway between the brain and stomach, controlling a subject’s feelings of hunger or fullness.

According to Reuters, the Maestro Rechargeable System “is implanted surgically into the abdomen and works by sending electrical pulses that interfere with the activity of the vagus nerve, which signals to the brain that the stomach is empty.”

A yearlong clinical study showed that patients implanted with the device lost only 8.5 percent more weight than the control group without the device, which fell short of the trial’s aim of weight loss of 10 percent or more.

However, an FDA advisory panel has reportedly concluded that the device provides sufficient benefits for certain patients. The device is the first of its kind approved by the FDA to treat obesity since 2007.


FDA Approved Obesity Treatment Devices

There are currently four categories of devices approved by the FDA to treat obesity. The following types of supported devices are:

  • Gastric Banding Systems
  • Gastric Balloon Systems
  • Gastric Emptying Systems
  • Electrical Stimulation Systems

New weight loss device approved by the FDA

The FDA approved a new weight loss technology, which is an implanted device to treat obesity. The device &ndash known as AspireAssist &ndash uses a tube to drain a portion of the stomach contents after each meal. The device is intended for individuals who are unable to lose weight and maintain weight loss using nonsurgical procedures. The device is approved for adults over the age of 22.

The device is intended for individuals with a body mass index over 35 &ndash a BMI over 30 is considered obese.

The device is intended for short-term use and is not advised for individuals with eating disorders.
The device only takes about five to 10 minutes to implant and removes roughly 30 percent of calories consumed in a meal.

The FDA approval is based on clinical trials involving 111 patients who used the device, along with a control group of 60 people who only changed lifestyle habits. After one year, the AspireAssist group lost on average 12 percent of their total body weight, whereas the control group lost only four percent.

Dr. William Maisel of the FDA said, &ldquoThe AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy. Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.&rdquo

Side effects of AspireAssist include indigestion, nausea, vomiting, constipation, and diarrhea. There are some risks associated with the placement of the device including pain, bleeding, infection, inflammation, and accidental puncture of the stomach or intestines.


FDA Approves New Appetite Pacemaker Device

Federal health officials approved a new obesity device Wednesday that controls appetite with electrical pulses.

It’s the first new obesity device to be approved by the Food and Drug Administration in more than seven years. Yet doctors admit they aren’t quite sure how it works.

The surgically implanted device, called Maestro, is designed to interrupt hunger signals from the brain to the stomach, and it’s manually controlled.

“The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes,” the FDA said in a statement.

Don’t look for it in stores – it’s likely only going to be offered at specialized clinics with trained surgeons. And don’t expect health insurance to pay for it any time soon, cautions NBC’s Diet & Nutrition editor Madelyn Fernstrom.

“Insurance likely, as with every new apparatus or pill, is not going to cover this,” Fernstrom says.

The device is implanted under the skin of the abdomen, with attachments placed just where the esophagus meets the stomach. It’s designed to interfere with the abdominal branch of the vagus nerve, a central nerve that controls the heart and digestive tract.

"VBLOC reduces feelings of hunger and promotes earlier feelings of fullness."

The company that makes the device, EnteroMedics Inc., designed it to interfere with hunger signals using a technology called VBLOC.

“By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss,” said Dr. Scott Shikora, chief consulting medical officer for EnteroMedics.

It should work in theory, says Fernstrom, but in fact it is not entirely clear if the device is interfering with hunger or acting in some other way.

"Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown," the FDA said.

EnteroMedics has been struggling to get it to the market. It was shown to work safely enough in trials on patients, although they didn’t lose a huge amount of weight – about 8.5 percent of their excess weight compared to people implanted with a sham device.

The FDA wanted the device to be 10 percent better, on average, than a placebo but has approved it anyway.

“As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions,” the FDA said.

“Serious adverse events reported in the clinical study included nausea, pain at the neuroregulator site, vomiting, as well as surgical complications. Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea and chest pain,” the agency added.

The need is enormous. More than two-thirds of Americans are overweight or obese and although there are several different drugs and devices on the market, most work best in limited populations such as the extremely obese.

“This is just another tool to put in the arsenal.”

Other devices include gastric bands that close off part of the stomach, a balloon that inflates inside the stomach, and various other surgical or stapling techniques to make the stomach smaller.

There's an appetite pacemaker, as well, that's approved in Europe but not the U.S.

Drugs include Qsymia, which pairs a stimulant with an epilepsy drug Contrave, which pairs an antidepressant with an addiction drug, Belviq, aimed to make people feel fuller, and phentermine, an appetite suppressant.

“Everyone is not going to be a candidate for this,” Fernstorm said. “This is just another tool to put in the arsenal.”

It won’t stop overeating that isn’t related to appetite, for one thing. “Most people are not just eating for hunger,” Fernstrom said.

Maggie Fox is a senior writer for NBC News and TODAY, covering health policy, science, medical treatments and disease.


The New Device to Treat Obesity: Is It for You?

Jan. 16, 2015 -- The FDA just approved the first new obesity device since 2007.

The Maestro Rechargeable System is a pacemaker-like implant that sends electrical pulses to the vagus nerve. The nerve extends from your brain to your stomach. It's involved in signaling the brain about whether the stomach is full or empty.

A committee of outside advisors to the FDA had concluded that the benefits of the Maestro System outweighed its risks. Most of the panel members agreed that the device was safe, but they were less enthusiastic about whether it worked: Four voted “yes” and five voted “no.”

WebMD asked two obesity experts involved in clinical trials of the device as well as the manufacturer, EnteroMedics, about how the Maestro System is supposed to be used and who might benefit.

Q. What parts make up the Maestro System?

A. It consists of a pacemaker-like electrical pulse generator, wire leads, and electrodes that are implanted in the abdomen. This surgery is a 60- to 90-minute outpatient procedure done while you're under general anesthesia, says EnteroMedics spokeswoman Jody Dahlman.

A. The system is programmed to deliver a pulse -- 5 minutes on and 5 minutes off -- to the vagus nerve during your waking hours, and it's supposed to turn off during the hours you sleep, Dahlman says.

Q. Who's a candidate for the Maestro System?

A. The FDA approved the device for the treatment of obese adults who have a body mass index (BMI) of at least 40, and for those with a BMI of at least 35 who have an obesity-related condition, such as high blood pressure or high cholesterol. Candidates are supposed to have tried to lose weight in a supervised weight-management program within the previous 5 years.

But once the FDA approves a device or a drug, doctors are free to prescribe it to any patient they think might benefit. The device could prove to be useful in helping extremely obese people lose some weight so they can more safely undergo gastric bypass surgery, says Caroline Apovian, MD. She's the director of nutrition and weight management at Boston Medical Center. The Maestro System also might help enhance weight loss after gastric bypass surgery, she says.

Continued

“I don’t have a good feel for who are going to be the ideal candidates,” says Ken Fujioka, MD, an obesity specialist at the Scripps Clinic in San Diego. Fujioka helped present data for EnteroMedics at the FDA advisory committee meeting last June. “You’re looking at weight loss that’s relatively similar to weight-loss drugs, and yet, you have to have a surgery.”

People who can’t tolerate weight-loss medications might benefit from the device, as might people with diabetes or pre-diabetes, he says. In clinical trials, the Maestro System appeared to have a good effect on blood sugar control on top of weight loss, Fujioka says.

“It does take a motivated patient,” he says. “You have to take care of this device. You have to charge it once or twice a week.” If the battery is allowed to totally drain, you need to see your doctor to have it reprogrammed, he says.

Q. How long is it left in place?

A. “This is intended to be a partner for life with patients,” Dahlman says. Some people have had it in place more than 7 years, she says. The battery lasts at least 8 years, at which point “it can be replaced relatively easily, probably with a local anesthetic.”

Q. What are the side effects?

A. In the clinical study, they included nausea, pain at the site the device was implanted, vomiting, surgical complications, heartburn, problems swallowing, belching, mild nausea, and chest pain, according to the FDA. “Some patients will feel a slight tingling when they first start the therapy, but it goes away when their body adjusts to the sensation,” Dahlman says.

Q. Why did the majority of the FDA advisory panel think it wasn’t effective?

A. In a clinical trial, the Maestro System “achieved exactly the amount of weight loss we thought we would get” after 1 year, Dahlman says.

However, one group of participants received the device, but (unbeknownst to them) it wasn't activated. Still, they lost more weight than expected. So the difference between those people and the group of participants whose devices got activated wasn’t that big after 1 year, Apovian says.

Continued

At that point, people who got the turned-on devices had lost only 8.5% more of their excess weight than those in the other group. The goal was for them to lose at least 10% more of their excess body weight, according to the FDA.

“If you think about it, it makes sense, because they [people who got a device that wasn't activated] underwent a surgical procedure,” Apovian said. “That is a group of patients who are extremely committed to getting weight loss. We think the placebo effect was very, very strong.” But after the first year, the people who got the device that wasn't turned on started gaining weight, while those who received the activated version continued to lose, she says.

All of the people in the clinical trials received counseling about diet and exercise, Fujioka says.

But the device alone won’t cause healthy weight loss. People do have to eat less and exercise more, Fujioka says. “This should help the person stay on track,” he says, because it should increase the feeling of fullness.

Q. How much does the Maestro System cost?

A. EnteroMedics spokeswoman Eliza Schleifstein says she can't provide an exact number. She did say that the price would fall between that of gastric bypass surgery and a gastric band device. Such surgeries can cost, on average, between $20,000 and $25,000, according to the National Institutes of Health.

Q. How soon can I get it?

A. At first, the Maestro System will be available only at obesity treatment centers that participated in the main clinical trial of the device, Schleifstein says. It won’t become more widely available until private and public insurers agree to cover it, and EnteroMedics can't say when that might be, she says.

Sources

News release, EnteroMedics.

Jody Dahlman, EnteroMedics.

Caroline Apovian, MD, director of nutrition and weight management, Boston Medical Center.


Weight loss 'pacemaker' gets FDA approval, first obesity device since 2007

To cure an irregular heartbeat, many Americans wear a pacemaker.

But what about for an irregular appetite?

The FDA approved the first pacemaker-like device to treat obesity on Jan. 14. It is the first device to treat obesity approved since 2007, the agency said. The last approved devices were gastric bands.

The VBLOC or Maestro system is surgically-implanted into the abdomen. Like a pacemaker, its sends electrical impulses through wires. But instead of going into the heart, VBLOC targets a nerve near the stomach that regulates appetite.

That nerve, called the abdominal vagus nerve, carries signals that tell the brain when the stomach is empty or full. VBLOC blocks those signals. The FDA said it's not quite sure why that results in weight loss.

Device manufacturer EnteroMedics, based in St. Paul, Minnesota, said VBLOC is an “entirely new approach” to treating obesity.

“By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness,” said EnteroMedics’ Chief Consulting Medical Officer Scott Shikora in a statement.

More than one-third of American adults are obese, according to the Centers For Disease Control and Prevention.

“Obesity and its related medical conditions are major public health problems,” said William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health in a statement. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”

The VBLOC is designed for people with a body mass index of 35 to 45 (severely obese) who also have another condition caused by their obesity, like diabetes or high blood pressure.

A clinical study compared two sets of patients who had a Maestro implanted, but the device was only activated for some of them. One year later, the group with the active device lost 8.5 percent more weight compared to the control group.

However, the study did not quite reach its goal of losing 10 percent more excess weight than the control group.

An FDA survey showed that patients are willing to accept the risks of surgery for the amount of potential weight loss.

The manufacturer, EnteroMedics, must now conduct a 5-year follow-up study.

Gavin Stern is a national digital producer for the Scripps National Desk.


The FDA Approved An Anti-Obesity Device&hellipBut Will It Work Long-Term?

When it comes to an FDA-approved treatment for obesity, there aren't a lot of options out there. Weight loss drugs such as Meridia have come and gone, since their risks have been found to outweigh their benefits. But here's some good news: Last week the FDA gave its seal of approval to a pacemaker-like device called the Maestro Rechargeable System (there are only two other FDA-approved weight loss devices on the market). Unlike diet pills of the past, this device is surgically implanted into the abdomen and sends intermittent electrical pulses to the abdominal vagus nerve&mdashbest known as the communicator between the brain and the stomach.

This nerve, which also is one of the longest nerves in our body, has been the target of anti-obesity research for years, since researchers have figured out that blocking its activity could aid in weight loss. "The vagus nerve is quite important in regulating communication along the gut-brain axis," says Christopher Ochner, PhD, an obesity and nutrition expert at The Mount Sinai Hospital in New York City. "We've come to realize just how vital the neurohormonal system is to the regulation of food intake and body weight. Therapies that alter signaling within this system are almost certainly the wave of the future."

Photo courtesy of EnteroMedics

Details about how the Maestro Rechargeable System actually works are unclear, but the FDA found the evidence to be favorable enough for approval. In a clinical trial that included 233 patients with a BMI of 35 or greater, of the 157 patients who received active Maestro devices, 52.5% lost at least 20% of their excess weight and 38% of them lost at least 25% of their excess weight. Overall, the experimental group lost 8.5% more of their excess weight than the control group after 12 months.

After evaluating the 18-month data, which showed sustained weight loss, the FDA Advisory Committee agreed that the benefits of the device outweighed the risks, which include nausea, pain at the site where the device is placed, vomiting, as well as surgical complications.

But the FDA wants more information. Though the Maestro is approved for treatment in adults over the age of 18 who have not been successful in losing weight with a program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition (like type 2 diabetes), the FDA is requiring the company that makes the device to conduct a five-year post-approval study. It will follow 100 patients to collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions. "How this system will fare in terms of long-term treatment effectiveness remains to be seen," Ochner says.


US approves new weight-loss device for obese people

US regulators on Wednesday approved a new kind of pacemaker-like device that aims to help people lose weight by stimulating a nerve that runs from the brain to the stomach.

The Maestro Rechargeable System is made by Minnesota-based EnteroMedics, and is the first device for weight loss approved by the US Food and Drug Administration in eight years.

Patients are surgically implanted with electrodes in the abdomen, and an externally-controlled electrical pulse generator sends signals to the abdominal vagus nerve, which helps signal to the brain if the stomach feels empty or full.

The FDA said the electrical stimulation "blocks nerve activity between the brain and the stomach," but that the "specific mechanisms for weight loss due to use of the device are unknown."

The device failed to meet its goal in a study of safety and effectiveness, in which it helped people lose 8.5 percent more of their excess weight than a control group that was given the device but it was not activated.

The goal had been 10 percent. The clinical trial included 233 patients with a body mass index (BMI) of 35 or greater.

However, about half of the patients that received the activated device lost at least 20 percent of their excess weight.

An advisory committee to the FDA recommended the device's approval based on 18 months of study that showed it could help some patients lose weight and keep it off.

"As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions," the FDA said.

Serious side effects have included nausea, pain at the neuroregulator site, vomiting, and surgical complications. Some users have also reported pain, heartburn, problems swallowing, belching, mild nausea and chest pain.

Christopher Ochner, an obesity and nutrition expert at The Mount Sinai Hospital in New York, said the device's approval is a "positive step."

"The vagal nerve, on which this system is designed to impart electrical impulses, is quite important in regulating communication along the gut-brain axis," he said.

"We have come to realize just how vital the neurohormonal system is to the regulation of food intake and body weight, and therapies that alter signaling within this system are almost certainly the wave of the future."

The FDA has now approved a total of three devices for weight loss, including the Lap-Band Gastric System and the Realize Gastric Band. Both work by limiting how much food can fit in the stomach.


FDA Approves New Weight-Loss Device

TUESDAY, June 14, 2016 (HealthDay News) -- A new surgically implanted device to treat obese patients has been approved by the U.S. Food and Drug Administration.

The AspireAssist device uses a tube to drain a portion of the stomach contents after every meal. It's meant to be used by people who have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for people 22 and older.

The device is recommended for obese people with a body mass index (BMI) between 35 and 55, the FDA said. BMI is a rough estimate of body fat based on height and weight measurements. A BMI of 30 or more is considered obese, according to the U.S. Centers for Disease Control and Prevention.

The device shouldn't be used in people with eating disorders. It also isn't intended for short-term use in moderately overweight people, according to the FDA.

With the AspireAssist, a tube is inserted in the stomach and connected to a port valve placed flush against the skin of the abdomen. About 20 to 30 minutes after each meal, the patient attaches an external connector and tubing to the port valve, opens the valve, and drains some stomach contents into the toilet.

The process takes five to 10 minutes and removes about 30 percent of the calories consumed in the meal, the FDA said.

The approval was based on the results of a clinical trial of 111 patients who used the AspireAssist and a control group of 60 patients who made lifestyle changes only. After one year, patients in the AspireAssist group lost an average of 12 percent of their total body weight. The control group lost an average of less than 4 percent of their weight, researchers said.

"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said Dr. William Maisel. He's the deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health.

"Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake," Maisel said in an agency news release.

Side effects associated with use of the AspireAssist include indigestion, nausea, vomiting, constipation and diarrhea. There are also a number of risks associated with the placement of the device, including pain, bleeding, infection, inflammation, accidental puncture of the stomach or intestinal wall, and death, the FDA said.


How safe is AspireAssist, the FDA-approved stomach pump weight loss device?

Diet drugs don’t work terribly well and doctors are reluctant to prescribe them. This new device is the first to remove food that people have already eaten before it can be digested.

The need is growing. The latest data from the Centers for Disease Control and Prevention shows that 38 percent of U.S. adults are obese, while 17 percent of teenagers fall under that category.

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said the FDA’s Dr. William Maisel.

“Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake,” he added.

On TODAY Wednesday, Roker agreed with that point: "As someone who has done gastric bypass and has struggled with it and knows even once you have it, it's not a panacea. You still have to do the work for it."

The company has not said how much it will charge for the device, which is on the market in Europe. A surgeon will also have to implant the device in a short endoscopic procedure, and that cost may vary by center.This new device is the first to remove food that people have already eaten before it can be digested.

“Patients require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against their skin. Frequent medical visits are also necessary to monitor device use and weight loss and to provide counseling on lifestyle therapies,” the FDA noted.

Side effects include indigestion, nausea, vomiting, constipation and diarrhea.

Obesity is calculated using body mass index (BMI) — a measure of height to weight — that's a score of 30.

People are considered overweight when their BMI hits 25.

Someone who is 5-foot-5 and weighs 149 pounds has a body mass index of 24, considered a healthy weight. Add a pound and the same person has a BMI of 25 and is considered overweight. At 180 pounds this person has a BMI of 30 and is considered obese.


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