Satiety — the feeling of fullness and disappearance of appetite after a meal — is exactly what Satiety (Palo Alto, California) wants to help patients achieve with its transoral gastroplasty (TOGa) procedure.

Satiety presented the first clinical results of its TOGa procedure — a transoral restrictive operation for obesity — at the American College of Gastroenterology meeting Monday in Las Vegas and is presenting it today at the United European Gastroenterology Week conference. The technology is touted by the company as a much less invasive procedure as compared to bariatric surgery

Using a plastic tube resembling a miniature hose and an endoscope to watch what is going on, doctors vacuumed the sides of the trial patients’ stomachs and applied two 4 cm staple lines to make the stomach smaller, Tom Gibson, Satiety spokesman, told Medical Device Daily.

“In essence the company takes the good parts of bariatric surgery – stapling the stomach so that it is much smaller – while eliminating the bad – piling patients’ intestines on their chests while the doctor re-plumbs their guts,” Gibson said.

The TOGa procedure is designed to be less invasive, require less recovery time and have reduced complications compared to existing surgical options, Satiety said.

Though the company is quick to tout the safety and feasibility data from the pilot trial, Jacques Deviere, MD, PhD, chairman of the Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium, the study author, emphasized that the procedure is still in the early trial stage and has only been done in 21 patients worldwide. However, he said he was impressed by the recovery time of the patients in the trial.

“This is true that we observed the recovery time for the patient is significantly shorter, there weren’t any abdominal incisions and in an obese patient abdominal incisions can be accommodated with significant complications,” Deviere told MDD in a phone interview from Belgium. “Even in the setting of a pilot trial the day after the procedure the patients were almost all ready to go back home and even one day later go back to work.”

In the 21 patients who participated in the trial, Deviere said there were no significant complications other than some mild post-operative pain. He said the most difficult part of the procedure is creating the staple lines.

“My concern is the risk related to the introduction of the device into the esophagus,” Deviere said. “This instrument is really easy to introduce but in my experience that’s surely the main concern at this stage.”

Deviere said the procedure would be most suitable for physicians experienced with using a flex endoscopy and should be performed in multidiscipline centers.

After one month, patients in the trial lost between 9 and 28 pounds representing 7% to 25% of their weight. Six patients were seen three months after their procedure and had lost between 14% and 29% of their weight. Deviere said the weight loss experienced by the trial patients appears to be similar to that of other surgeries but he said the procedure’s effectiveness is best evaluated after a year and it has only been about eight months.

Greg Patterson, CEO of Satiety, told MDD that performing the procedure on humans was a huge milestone. Patterson said the goal of the pilot trial was to prove the safety of the operation.

“The fact that the patients in the trial also experienced weight loss is just icing on the cake,” Patterson said.

Satiety says it expects to get the TOGa procedure approved in Europe in 2008 and in the U.S. in 2010.

Deviere said the procedure is most likely to be successful for a patient who is able to eat a large amount of food in a short amount of time because the staples will make the patient feel full sooner. The procedure won’t work as well, Deviere said, for the sweet-eater who consumes a lot of sugar and soda because the TOGa operation would not prevent that from passing through the stomach.

Gibson said there are several procedures in the works designed to be less invasive than bariatric surgery. In Europe, he said, doctors have been inserting a balloon down the throat and through the esophagus of obese patients to close off the stomach.

“There are some problems with that. Sometimes a patient can only have a balloon in their stomach for about six months, and it has to be removed and put in again and for whatever reason the body rejects the second balloon,” Gibson said. “Other problems associated with the balloon is it could be digested and go down into the intestines and that’s not good at all.”

About 22 million adults in the U.S. are considered morbidly obese, Satiety said, and about 170,000 surgical procedures were done on those patients in 2005.

Satiety, founded in 2001 by serial inventor and entrepreneur Thomas Fogarty, MD, of The Foundry (Menlo Park, California), develops tools for endoscopists and gastrointestinal surgeons with technology to support the treatment of obesity.

No Comments