Senior Staff Writer

The market for weight loss devices has seen a flurry of recent activity, most recently with the FDA approval of an intragastric dual balloon system from Reshape Medical (San Clemente, Calif.).

The FDA approved Reshape's weight loss procedure in adults with a BMI of 30 to 40 kg/m2 and a related health condition who have not been able to lose weight with diet and exercise alone and do not want or qualify for bariatric surgery.

Single intragastric balloons have been available outside the U.S. for about 30 years, Rick Thompson, president/CEO of Reshape Medical, told Medical Device Daily.

"We know single balloons work, but there is room to improve," Thompson said.

The Reshape dual balloon system is inserted in the stomach endoscopically and filled with saline. The balloons are left in the stomach for six months and then removed.

The dual balloon design offers three big advantages over the single balloon devices, he said. First, because the system includes two balloons used at the same time, the Reshape system occupies more space in the stomach so patients eat smaller meals, with the goal of losing more weight. Single balloons hold about 500 CCs of saline, whereas Reshape's balloons hold a total of 900 CCs (about 450 CCs in each balloon), Thompson said.

The Reshape balloons are attached to a flexible shaft that allows the balloons to conform to the natural shape of the patient's stomach. Thompson said the flexible design was intended to make the dual balloon more tolerable than single intragastric balloons, even though it's bigger.

The Reshape balloon also offers some safety advantages over traditional single balloon devices, Thompson said. He said the biggest risk with intragastric balloons is that they sometimes deflate prematurely and move into the intestines, causing a dangerous bowel obstruction that often requires emergency surgery. Reshape designed the two balloons in its system to be independent of each other so that if one balloon deflates, the other should stay inflated and act as an anchor in the stomach to prevent the device from moving into the intestines.

As another precaution, Thompson said the Reshape balloons have blue dye in the saline and patients are trained to call their doctor if they see blue dye in their urine indicating a possible deflation.

"This is the first non-surgical weight loss device approved in the U.S. since the mid-80s," Thompson said.

As with most of the weight loss procedures currently in development or on the market, Reshape patients are expected to participate in a 12-month program to learn how to modify their behavior and eat smaller meals even after the balloon is removed. The idea behind the educational component of the process is to help patients maintain the weight loss long term.

Last year the company published a study that showed 50% of Reshape patients were still losing weight at the end of the 12-month program, even six months after the balloons were removed.

"With the right program you can be really successful with this, even though the balloon is out," Thompson said.

Most of the device makers in this sector face challenges on the reimbursement front. Thompson said Reshape plans to pursue reimbursement from private payers sometime in the future, but currently the company expects to market Reshape as a self-pay procedure.

"We believe plenty of patients are willing to pay out of pocket," he said.

The company does offer a financing plan for pre-qualifying patients.

Now that the device is approved in the U.S., Thompson said the product will be launched within a few weeks on a limited basis.

"Our approach is to go to a limited number of sites to make sure we've really nailed it, that our procedure is working in the U.S. the way we know it works in Europe," Thompson said.

John Morton, president of the American Society for Metabolic and Bariatric Surgery, said options like Reshape address a gap that exists between diet and exercise, weight loss medications, and surgery.

The Reshape system was evaluated in the REDUCE pivotal trial. In that study, patients with the Reshape procedure lost 2.3 times as much weight as patients in the control group who received diet and exercise coaching only. There were also measurable and sustained improvements in comorbidities and strong patient satisfaction, according to the company.

In a study of Reshape in commercial use in Europe, Reshape patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year.

Senior Staff Writer

The market for weight loss devices has seen a flurry of recent activity, most recently with the FDA approval of an intragastric dual balloon system from Reshape Medical (San Clemente, Calif.).

The FDA approved Reshape's weight loss procedure in adults with a BMI of 30 to 40 kg/m2 and a related health condition who have not been able to lose weight with diet and exercise alone and do not want or qualify for bariatric surgery.

Single intragastric balloons have been available outside the U.S. for about 30 years, Rick Thompson, president/CEO of Reshape Medical, told Medical Device Daily.

"We know single balloons work, but there is room to improve," Thompson said.

The Reshape dual balloon system is inserted in the stomach endoscopically and filled with saline. The balloons are left in the stomach for six months and then removed.

The dual balloon design offers three big advantages over the single balloon devices, he said. First, because the system includes two balloons used at the same time, the Reshape system occupies more space in the stomach so patients eat smaller meals, with the goal of losing more weight. Single balloons hold about 500 CCs of saline, whereas Reshape's balloons hold a total of 900 CCs (about 450 CCs in each balloon), Thompson said.

The Reshape balloons are attached to a flexible shaft that allows the balloons to conform to the natural shape of the patient's stomach. Thompson said the flexible design was intended to make the dual balloon more tolerable than single intragastric balloons, even though it's bigger.

The Reshape balloon also offers some safety advantages over traditional single balloon devices, Thompson said. He said the biggest risk with intragastric balloons is that they sometimes deflate prematurely and move into the intestines, causing a dangerous bowel obstruction that often requires emergency surgery. Reshape designed the two balloons in its system to be independent of each other so that if one balloon deflates, the other should stay inflated and act as an anchor in the stomach to prevent the device from moving into the intestines.

As another precaution, Thompson said the Reshape balloons have blue dye in the saline and patients are trained to call their doctor if they see blue dye in their urine indicating a possible deflation.

"This is the first non-surgical weight loss device approved in the U.S. since the mid-80s," Thompson said.

As with most of the weight loss procedures currently in development or on the market, Reshape patients are expected to participate in a 12-month program to learn how to modify their behavior and eat smaller meals even after the balloon is removed. The idea behind the educational component of the process is to help patients maintain the weight loss long term.

Last year the company published a study that showed 50% of Reshape patients were still losing weight at the end of the 12-month program, even six months after the balloons were removed.

"With the right program you can be really successful with this, even though the balloon is out," Thompson said.

Most of the device makers in this sector face challenges on the reimbursement front. Thompson said Reshape plans to pursue reimbursement from private payers sometime in the future, but currently the company expects to market Reshape as a self-pay procedure.

"We believe plenty of patients are willing to pay out of pocket," he said.

The company does offer a financing plan for pre-qualifying patients.

Now that the device is approved in the U.S., Thompson said the product will be launched within a few weeks on a limited basis.

"Our approach is to go to a limited number of sites to make sure we've really nailed it, that our procedure is working in the U.S. the way we know it works in Europe," Thompson said.

John Morton, president of the American Society for Metabolic and Bariatric Surgery, said options like Reshape address a gap that exists between diet and exercise, weight loss medications, and surgery.

The Reshape system was evaluated in the REDUCE pivotal trial. In that study, patients with the Reshape procedure lost 2.3 times as much weight as patients in the control group who received diet and exercise coaching only. There were also measurable and sustained improvements in comorbidities and strong patient satisfaction, according to the company.

In a study of Reshape in commercial use in Europe, Reshape patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year.

No Comments