A recent article in the Orange County Register reports the first U.S. clinical trials are to begin this spring on an intragastric balloon developed by ReShape Medical in San Clement, CA.
The device is reportedly a double-balloon mechanism that is inserted endoscopically using the ReShape delivery system down the patient’s throat with a tube attached and inflated with saline. The ReShape intragastric balloon is designed to fit in the stomach to fill the stomach area and give the patient the feeling of being full, thus reducing the ability for the patient to intake food.
According to the product page on the company’s website, “the ReShape intragastric balloon is comprised of two balloons attached to each other by a flexible tube. Each balloon has independent channels so that unintentional leaks or deflation in one balloon are designed not to impact the other balloon. The device is used in conjunction with diet and exercise.”
Medgadget, which also reported on this new development, says the procedure is done on an outpatient basis and the device can be removed, unlike gastric banding.
According to the OC Register, this potential less-invasive weight loss option could be a solution for patients who fall just below or above the eligibility guidelines for the two popular forms of bariatric surgery—gastric bypass and laparoscopic gastric banding.
Additionally, this procedure could be done in patients as young as 13 who are severely obese, but considered too young for other forms of bariatric surgery. As the OC Register reports, in a study released by Centers for Disease Control and Prevention last month, 18.1 percent of U.S. children age 12-19 are considered obese.
ReShape Medical’s vice president of research and development, Mark Ashby, told the OC Register that this balloon’s design is an improvement over its predecessors because of it has two balloons. An early version of this type of device, the Garren-Edwards gastric bubble, was introduced in 1984, but would sometimes rupture. With no backup membrane, the bubble would slip into the small intestine and cause a dangerous blockage.
According to Ashby, approximately 100 of the ReShape balloons have been implanted in patients in Italy and Poland and the safety and efficacy feedback has been good.
It should also be noted that ReShape paying for the studies, including the procedures and the intensive follow-up education and treatment for patients during the initial trial phase. The trials will involve 30 patients at three medical centers.