Gastric Sleeve Magnetic Implant
Department of Health and Human Services
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Small Business Information
3DT HOLDINGS, LLC
3DT HOLDINGS, LLC, 251 N. Illinois Street, INDIANAPOLIS, IN, 46204
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The occurrence of obesity is increasingly growing, and it has been projected that 40% of the US population will be obese by the year 2025. The World Health Organization estimates over 1.6 billion adults (age 15+) are overweight, and at least 400 million are considered obese. In response, there has been increasing interest in the surgical treatment of morbid obesity with the application of laparoscopic techniques. Our major objective is to establish the safety and efficacy of a Vertical Sleeve Gastrectomy, VSG-like device referred to as the gastric sleeve implant (GSI). The major advantage of GSI is that it does not require gastrectomy and hence leaves the anatomy and physiology of the stomach intact. Furthermore, the implant is reversible and can be removed if desired by the patient and physician. In phase I of this SBIR, we will focus on the validation of the GSI in an in vivo dog model. Therefore, our specific aim is to evaluate the safety and efficacy of a reversible GSI for weight loss in a group of dogs. The device is designed to be implanted laparoscopically, and to be readily removed after implantation if desired, leaving the patient's anatomy healthy, intact, and physiologically normal. The net result of the GSI procedure is a vertical sleeve, or banana-shaped, food track, which is a fraction of the size of the original stomach. The stomach tissue excluded from the food track remains healthy and unharmed, but the digestive volume is restricted to limit the patient's food intake. The GSI mimics the benefits of the increasingly popular VSG, but it inherently avoids some of the shortcomings of the VSG and other commonly used bariatric procedures. These current procedures all suffer from one or more of the following shortcomings: 1) Leaks and complications, especially from staple lines; 2) Nutritional deficiencies from malabsortive therapies; 3) Frequent follow-up appointments for adjustments; and 4) Insufficient and/or unsustained weight loss amongst others. The design of the proposed GSI and our preliminary data address some of these shortcomings. PUBLIC HEALTH RELEVANCE: The major objective of this proposal is to establish the safety and efficacy of an implant bariatric device. The major advantage of this weight loss device is that it does not require excision and removal of the stomach and hence leaves the anatomy and physiology of the stomach intact. Furthermore, the implant is reversible and can be removed if desired by the patient and physician leaving the stomach healthy and intact.
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