Full Sense(TM) Device completes successful clinical evaluation
GRAND RAPIDS, Mich., Feb. 13 /PRNewswire/ -- Sentinel Group announced the completion of the first study of the Full Sense(TM) Device. The study was conducted at Galenia Hospital in Cancun, Mexico by American doctors Randal Baker MD, James Foote MD and Mexican doctor Jorge Trevino MD. The study protocol was designed to have the devices implanted for 6 weeks to evaluate weight loss, satiety (lack of hunger), safety, and removability.
The Full Sense(TM) Device is a stent like device placed through the mouth into the top of the stomach to cause satiety thus decreased hunger and increased fullness. It causes satiety by placing pressure on the bottom of the esophagus and the top of the stomach.
Patients not only lost significant weight in the study but also noted significant satiety with the device in place. Without the device they noted extreme hunger before meals whereas with the pressure from the Full Sense(TM) Device they experienced at most slight to no hunger before meals. The devices were removed safely and patients have stopped losing weight and are beginning to regain the weight that they had lost.
"The patients were extremely happy with the lack of hunger and resulting weight loss. They did not want the devices removed but reluctantly underwent removal per the protocol to demonstrate that the device could be easily removed," said Fred Walburn, PhD., President of Sentinel Group. "This technology represents potentially a new era of safe non-surgical weight loss treatment and offers hope for the millions of Americans who need treatment for obesity but can't afford the cost or possible complications of traditional weight loss surgery."
"Obesity is increasingly causing devastating effects on individuals and our society as a whole. This technology, I believe, offers the best opportunity yet to deliver consistent satiety and weight loss. Even many people with traditional weight loss surgery are experiencing significant hunger and subsequent weight regain. The potential to deliver satiety without classic incisions and surgery will give hope to many more people struggling with weight and weight related medical conditions," stated Randal Baker MD.
"The patients were very pleased with the results of the Full Sense(TM) Device," said Dr. Trevino, Head of Bariatric Surgery. "They are asking for the device to be implanted again!"
The Galenia Hospital located in Cancun, Quintana Roo, Mexico is a modern facility with state of the art equipment which goes beyond the everyday services, with highly trained doctors and a wide range of medical specialties along with experienced people working for health care of national and international patients.
ABOUT SENTINEL GROUP
Sentinel Group is a medical device development company founded to commercialize patents owned by its principals and to assist physician inventors in commercializing their ideas. The company's intellectual property portfolio includes technologies in the areas of: bariatrics, colorectal anastomoses, diverticulitis, hiatal hernia, depression, Natural Orifice Translumenal Endoscopic Surgery (NOTES), Endoscopy and GERD. The Company's first product is the Full Sense(TM) Bariatric Device.
The Full Sense(TM) Device is not available in all markets pending regulatory clearance. Sentinel Group(R) and Full Sense(TM) Device are trademarks of Sentinel Group LLC.
|SOURCE Sentinel Group|
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