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AspireAssist weight loss device schematic
More effective than drugs "weight loss" Yixie <br> <br> in recent years, although the FDA approved a number of new weight-loss drugs, but are less significant because of the effect and the lack of reimbursement policies have failed to generate significant sales results. This situation provides medical device manufacturers with an excellent opportunity to provide more effective treatment options for obese people than diet pills.
On June 14th, the US FDA officially approved a slimming device called “AspireAssistâ€. People can let go of the belly and eat it, without worrying about obesity. The weight-loss device can help people to take undigested food in the stomach. Extracted from the body. This device is manufactured by AspireBariatrics.
The principle of the "AspireAssist" weight loss device "AspireAssist" weight loss device is a small handheld "gastric pump" that can directly suck out some food in the stomach 20 minutes after a meal and discharge it into the toilet, leaving only about 1/3 of calories. For the body to absorb.
First, the patient needs to undergo a 15 minute minor surgery to insert a catheter through the abdomen into the stomach;
Then, after fixing one end of the catheter, a small water pump is connected to the outlet end, and the water is continuously supplied to the stomach through the water pump;
Finally, the medical device pumps the liquid mixed with undigested food from the stomach within 5-10 minutes and draws it into a bag.
When obese patients do not use the instrument temporarily, they only need to plug the catheter end that is placed in the stomach with a special stopper. The “AspireAssist†weight loss device draws at least 1/3 of the undigested food from the stomach after each meal.
FDA approves the "AspireAssist" weight loss device considerations 1) Applicable people:
a. The AspireAssist device is not intended for use in patients with eating disorders and does not tend to be used only in patients who are moderately overweight in the short term;
b. The AspireAssist device primarily assists patients 22 years of age and older with a BMI of 35 to 55 and is unable to achieve and maintain weight loss through non-surgical weight loss treatment.
William Maisel, deputy director of science and chief scientist at the FDA Center for Medical Devices and Radiation Health, said AspireAssist is an effective way to control calorie (calorie) absorption. Calorie is the leading cause of obesity. These patients using the AspireAssist device require regular monitoring and follow-up lifestyles to help them develop healthy eating habits and reduce calorie intake.
2) Clinical data:
The FDA reviewed the results from a clinical trial http://i.bosscdn.com/blog/63/64/37/698952935948354.jpg patients treated with AspireAssist and appropriate lifestyle treatment, and 60 control patients received only Lifestyle treatment.
One year later, AspireAssist patients lost an average of 12.1% of their overall weight, compared with 3.6% of the control patients.
Clinical trial results also suggest that the two groups of patients often have small improvements, such as diabetes, hypertension, and quality of life obesity, improved or derived from lifestyle treatments, including nutrition and exercise counseling.
3) Side effects:
AspireAssist uses related side effects including occasional indigestion, nausea, vomiting, constipation and diarrhea.
Endoscopic surgery placement of the stomach tube is associated with risks including sore throat, pain, bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the abdominal lining, medial ulcer of the stomach, pneumonia, stomach or The small intestine wall was accidentally punctured and died.
Risks associated with port valve abdomen opening include abdominal discomfort or pain, skin irritation around the placement site, hardening or inflammation, leakage, bleeding and/or infection around the placement site and movement of the device into the stomach wall. All have the necessary removal device. After removal of the device, there may be a risk of persistent fistula, an abnormal passage between the stomach and the abdominal wall.
4) Disable the crowd:
Disabled populations include uncontrolled high blood pressure, diagnosed bulimia, diagnosed binge eating disorder, nocturnal eating syndrome, certain types of previous abdominal surgery, pregnancy or breastfeeding, inflammatory bowel disease, or stomach ulcers.
In addition, AspireAssist is also contraindicated in patients with a history of severe lung or cardiovascular disease, coagulopathy, chronic abdominal pain, or from a high-risk patient with endoscopic medical complications.
Inventory: FDA approved weight loss "medical equipment" over the years
1) ORBERA intragastric balloon system In August 2015, the FDA approved Apollo Endosurgery, a new intragastric balloon weight loss device Orbera Intragastric Balloon (ORBERA intragastric balloon system), approved by the FDA for body mass index (BMI) at 30- A 40 kg/m2 group of obese adults used to lose weight and maintain weight.
This is a kind of intragastric balloon weight loss device, which uses the balloon to occupy the stomach space to achieve weight loss. It needs to be removed after being placed in the stomach for 6 months. The device consists of a balloon that is placed into the stomach from the mouth by minimally invasive endoscopic surgery, followed by infusion of physiological saline to expand it into a spherical shape. Different volumes of normal saline (400-700 ml) can be injected into the ball to form the best match with the patient's body structure.
Applicable people: Adults with obesity who have a BMI between 30-40 and cannot successfully lose weight through diet and exercise.
2) Reshape intragastric double balloon system At the end of July 2015, the FDA approved a new integrated intragastric balloon weight loss device, IntegratedDualBalloonSystem from ReShape Medical.
This is a kind of intragastric balloon weight loss device, which uses the balloon to occupy the stomach space to achieve weight loss. It needs to be removed after being placed in the stomach for 6 months. The system consists of two balloons. The balloon is placed into the stomach from the mouth by minimally invasive endoscopic surgery, and then 2 cups of saline and a blue dye (methylene blue) are injected into the balloon. If the balloon ruptures, the blue dye will appear in the patient's urine.
Applicable people: BMI between 30-40, accompanied by at least one obesity-related disease (such as diabetes, high blood pressure, high blood lipids), obese adults who cannot lose weight through diet and exercise.
3) Maestro Electrical Stimulation System In January 2015, the FDA approved the Maestro Rechargeable System (Maestro Respiratory System) from EnteroMedics.
This is an appetite control device that surgically implants the abdomen to block nerve activity between the brain and the stomach. The device consists of a rechargeable electrical pulse generator, lead, and electrodes that help adults with obesity 18 years of age and older lose weight.
The Maestro System works by sending intermittent electrical pulses to the vagus nerve. The vagus nerve is involved in regulating the fasting sensation of the stomach and sending a signal to the brain that the stomach feels hungry or full. An external controller allows the patient to charge the device and allows the healthcare provider to adjust the settings of the device to provide optimal treatment and minimize side effects. Although electrical stimulation is currently known to block neural activity between the brain and the stomach, the specific weight loss mechanism of the device is not yet clear.
Applicable people: Adult obese patients aged 18 and over who have experienced at least one weight loss program failure in the past 5 years, and obese adult patients with BMI between 40 and 45, BMI between 35-39.9 with at least one Adult obese patients with obesity-related diseases such as diabetes, high blood pressure, and sleep apnea.
4) Realize Adjustable Gastric Banding System In 2007, FDA approved Ethicon's RealizeGastricBand (Realize Adjustable Gastric Banding System), which limits the total amount of food consumed at one time, while increasing the time of food digestion, helping people eat more. less.
This is a surgical implant device that helps adults 18 years of age and older lose weight. RealizeBand consists of a silicone ring, a tube and an interface.
Applicable population: an adult population of obesity with a BMI ≥ 40, and an adult population of obesity with a BMI ≥ 35 accompanied by at least one obesity-related disease. The RealizeBand gastric band is only suitable for adult patients who have lost weight in non-surgical procedures (eg diet control, exercise and behavior correction programs).
5) Lap-Band Adjustable Gastric Banding System In 2001, the FDA first approved the Lap-Band Gastric Banding System produced by Allergan (Lap-Band Adjustable Gastric Banding System). In 2011, it was approved to expand the population. And sold to Apollo Endosurgery in 2013.
This is a surgical implant device that helps adults 18 years of age and older eat less and lose weight. Lap-Band consists of a silicone ring, a tube and an interface. The inner surface of the silicone ring is inflatable and is connected to the interface by a tube. Lap-Band limits the amount of food you eat at one time and increases the time it takes for food to digest, helping people eat less.
Applicable population: an adult population of obesity with a BMI ≥ 40, and an obese adult population with a BMI between 30-40 and at least one obesity-related disease such as hypertension, heart disease, diabetes, sleep apnea. The Lap-Band gastric band is only suitable for adult patients who have lost weight due to non-surgical methods (such as diet control, exercise and behavior correction programs).
In summary, in the face of more and more obese people, we no longer rely solely on diet or drug therapy to lose weight, scientists are using an open mind and vision to develop a variety of ways to help lose weight.
Stomach pump weight loss instrument easy round your weight loss dream
Original title: FDA approved gastric pump, "want to eat, eat and lose weight" era or arrival [ China pharmaceutical network technology dynamic ] When obesity becomes a disease, when more and more people face obesity, what should I do? On June 14, the US FDA officially approved a weight loss device called "AspireAssist", which can help people extract undigested food from the stomach. Does this mean that we can let go of eating without worrying about getting fat, and imagine what kind of sensation this device will cause in the market.
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