The Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System, which are gastric-balloon systems that FDA approved in 2015, are placed in the stomach through the mouth via a minimally invasive endoscopic procedure while the patient is under mild sedation. After the balloon is in place, the Orbera and ReShape balloons are filled with saline. Experts say Obalon’s use of gas creates fewer adverse reactions, such as discomfort, nausea, ulceration and vomiting, than do the saline-based systems. We also were told that the cost of either procedure compares with the cost of Obalon.
FINDING NEW TREATMENTS. The recently passed 21st Century Cures Act is intended to build on FDA’s efforts to expedite medical-product innovation by creating the breakthrough device pathway, which builds on the expedited-access pathway.
A fourth new minimally invasive obesity device, Aspire Bariatrics’ AspireAssist, is a gastric-emptying system that gained FDA approval in June 2016. The device helps patients to lose weight through a surgically placed tube that drains a portion of the stomach’s contents after every meal. AspireAssist requires frequent monitoring by a health-care provider, who shortens the tube as a patient loses weight. Katherine D. Crothall of Aspire Bariatrics says the device benefits patients who have a BMI of 35–55 kg/m2 and don’t want to undergo bariatric surgery. The treatment costs $8,000–$9,000, or one-third of the cost of bariatric surgery, Crothall says. She tells us that AspireAssist isn’t covered by insurance plans, but the company is speaking with several insurance companies in hopes that they’ll cover the device.
David Filmore of Medtech Insight, which is an industry publication, says minimally invasive obesity devices won’t make existing devices and obesity surgeries obsolete. He says bariatric surgery has a more pronounced effect on weight loss for those who have a BMI of at least 35 kg/m2. However, Filmore says gastric-balloon and gastric-emptying systems are beneficial, because they expand obesity-treatment to patients who don’t qualify for bariatric surgery.
ARTIFICIAL PANCREAS. Device manufacturers are developing diabetes treatments, too. Medtronic gained FDA approval in September 2016 for its Mini-Med 670G hybrid closed-loop system, which is the first FDA-approved device that measures and delivers basal insulin 24 hours per day in type 1 diabetes patients who are age 14 and older.
CDC estimates that about 5 percent of diabetes patients have type 1 diabetes, or juvenile diabetes, which typically is diagnosed in children and young adults.
Often referred to as an “artificial pancreas,” the MiniMed 670G adjusts insulin levels by measuring glucose levels every 5 minutes and delivering or withholding insulin automatically. Patients only have to enter the amount of carbohydrates that they consume into the system and have to calibrate the system’s sensor periodically.
ARTIFICIAL PANCREAS. The MiniMed 670G is the first FDA-approved device that measures and delivers basal insulin 24 hours per day.
“[It’s] designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels,” says Alejandro Galindo of Medtronic. “The feedback we’ve heard from patients and caregivers in the clinical trial is that patients are able to trust the system and rest uninterrupted throughout the night. This has significant quality-of-life benefits, particularly for those who have struggled with the nighttime routine, which can be stressful and burdensome.”
American Diabetes Association says the MiniMed 670G breakthrough ultimately will lead to a fully automated closed-loop system that won’t require patients to enter the amount of carbs that they consume into the system.
Aaron Kowalski of Juvenile Diabetes Research Foundation says that, even though the United States is one of the more advanced countries in diabetes treatment, it still is difficult for people who have type 1 diabetes to manage their glucose levels. That puts them at risk for long-term complications, which include blindness and kidney disease, he says.
“Taking the burden off the shoulders of people, I think it really is going to be a big step forward,” he says.
Galindo says the MiniMed 670G system will be available in spring 2017. Medtronic expects that the system will cost the same—$6,000–$9,000—as its current pump systems do. Medtronic says the system will be covered by insurance, and the company will have more information about coverage when the device is available.
DISAPPEARING ACT. Coronary heart disease develops when cholesterol-containing deposits accumulate in coronary arteries and narrow those arteries, which decreases blood flow to the heart. The disease is responsible for about 370,000 deaths each year in the United States, according to National Heart, Lung and Blood Institute, which is part of National Institutes of Health (NIH).