There has been no new medical device to treat obesity approved by the FDA in more than a decade. A series of companies are hoping to be the first, including ReShape Medical, which has filed a PMA with the FDA for its ReShape Integrated Dual Balloon System aimed at weight loss for the obese with a body mass index from 30 to 40.
Approved drugs have limited efficacy, as well as off-target safety concerns, and surgery is an extreme and expensive measure undertaken by only a few. Endoscopic devices hope to fill that gap between drugs and surgery.
The company said it's the first device to meet its primary efficacy endpoints in a U.S., randomized, sham-controlled pivotal trial for weight loss. The submission includes data from the company's REDUCE trial with 326 patients at 8 U.S. sites. The company reported that the REDUCE trial met its primary endpoints last November, but did not detail the data. ReShape will present the data in full at the Nov. 2-7 conference for the American Society of Metabolic and Bariatric Surgery conference in Boston, MA.
Reshape President and CEO Richard Thompson said in an interview that he expects the FDA review period to be less than the typical one of about a year. "We believe that FDA is looking to get products on the market, so this could be a more accelerated review," he said.
He noted that patients in the REDUCE trial were highly satisfied with their devices. In a survey after the trial, two-thirds said they would be happy to go through the entire experience again, while three-quarters said they would recommend it to a friend.
In 2011, a Phase I trial in 21 patients with a BMI of 30 to 40 demonstrated an average loss of 32% of excess weight. These patients maintained much of this weight loss after the device was removed, ReShape said. There are 50 million Americans who have a BMI of 30 to 40.
ReShape's PMA filing comes shortly after last month's mixed panel vote for a vagal nerve blocker to treat obesity from EnteroMedics. The FDA Gastroenterology and Urology Devices panel narrowly voted against its Maestro System on the crucial issue of efficacy in a 4-to-5 vote on June 17. Its Maestro System had failed to meet either primary endpoint in a pivotal trial.
Another device targeting the ample U.S. obesity market is EndoBarrier from GI Dynamics; it is currently in a pivotal trial to treat type II diabetic patients who are also obese. This is a gastric liner, which is placed endoscopially in the patient's intestine to prevent the absorption of some calories and nutrients. Data presented at the recent American Diabetes Association conference showed that EndoBarrier resulted in a drop in average daily glucose by 29% within days post implantation, despite a reduction of 50% in insulin dose during this time.
ReShape's system is inserted endoscopically during an outpatient procedure in which the system is inserted and inflated to reduce stomach size and help patients feel full. It remains in the stomach for 6 months, a timeframe that is similar to that of the EndoBarrier. Likely issues for both devices are how long weight loss can be maintained once the device is removed and if repeat usage is a safe and effective option.
Both of these devices have long been marketed ex-U.S. and have been available in the EU under the CE mark for years, so long-term post-marketing data could be part of their U.S. regulatory packages.
- here is the press release